ReagentsInfectious diseasesOther infectious immunology/NAT

Infectious immunology

EMDN code W01059001

158 manufacturers, 866 models including 847 on the market, 28 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 158

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	AGAROSE GEL DNA EXTRACTION KIT S AUTOMATED BACTERIAL DNA EXTRACTION KIT AUTOMATED EXTRACTION KIT VIS100231 cDNA SENTEZ KİTİ COVID 19 SAMPLING AND VIRAL RNA EXTRACTION KIT S2 refs 58 others DRIED BLOOD RNA EXTRACTION S KIT EXTRACTION KIT VIS100232 GENERAL DNA/RNA EXTRACTION KIT VIS100300 Manuel Viral/ Bacterial Extraction kit for Blood Samples Manuel Viral/ Bacterial Extraction kit for Serum Samples Manuel Viral/ Bacterial Extraction kit for Stool Samples Manuel Viral/ Bacterial Extraction kit for Urine Samples PLASMID DNA EXTRACTION KIT S PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T1 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T2 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T3 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T4 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T5 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T6 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T7 PURIFY AUTOMATED DNA&RNA EXTRACTION KIT T8 PURIFY AUTOMATED RNA EXTRACTION KIT PURIFY BACTERIAL DNA EXTRACTION KIT M PURIFY BAKTERİYEL DNA EKSTRAKSİYON S KİTİ PURIFY BAKTERİYEL RNA EKSTRAKSİYON M KİTİ PURIFY BAKTERİYEL RNA EKSTRAKSİYON S KİTİ PURIFY BİTKİ DNA EKSTRAKSİYON M KİTİ PURIFY BİTKİ DNA EKSTRAKSİYON S KİTİ PURIFY BİTKİ RNA EKSTRAKSİYON M KİTİ PURIFY BİTKİ RNA EKSTRAKSİYON S KİTİ PURIFY DNA EXTRACTION KIT S PURIFY DOKU DNA EKSTRAKSİYON M KİTİ PURIFY DOKU DNA EKSTRAKSİYON S KİTİ PURIFY DOKU RNA EKSTRAKSİYON M KİTİ PURIFY DOKU RNA EKSTRAKSİYON S KİTİ PURIFY DRIED BLOOD DNA EXTRACTION S KIT PURIFY GAİTA DNA EKSTRAKSİYON M KİTİ PURIFY GAİTA DNA EKSTRAKSİYON S KİTİ PURIFY GAİTA RNA EKSTRAKSİYON M KİTİ PURIFY GAİTA RNA EKSTRAKSİYON S KİTİ PURIFY GENOMIC DNA EXTRACTION KIT S PURIFY KEMİK DNA EKSTRAKSİYON M KİTİ PURIFY KEMİK DNA EKSTRAKSİYON S KİTİ PURIFY KEMİK RNA EKSTRAKSİYON S KİTİ PURIFY KÜF-MAYA DNA EKSTRAKSİYON M KİTİ PURIFY KÜF-MAYA DNA EKSTRAKSİYON S KİTİ PURIFY KÜF-MAYA RNA EKSTRAKSİYON M KİTİ PURIFY KÜF-MAYA RNA EKSTRAKSİYON S KİTİ PURIFY OSTEOID RNA EXTRACTION KIT M PURIFY RNA EXTRACTION KIT S PURIFY SALIVA RNA EXTRACTION S KIT PURIFY TAM KAN DNA EKSTRAKSİYON M KİTİ PURIFY TAM KAN DNA EKSTRAKSİYON S KİTİ PURIFY TAM KAN RNA EKSTRAKSİYON M KİTİ PURIFY TAM KAN RNA EKSTRAKSİYON S KİTİ PURIFY VIRAL DNA/RNA EXTRACTION KIT S PURIFY VİRAL DNA EKSTRAKSİYON M KİTİ PURIFY VİRAL DNA EKSTRAKSİYON S KİTİ PURIFY VİRAL RNA EKSTRAKSİYON M KİTİ PURIFY VİRAL RNA EKSTRAKSİYON S KİTİ TAM KANDAN RNA EKSTRAKSİYON KİTİ VIRAL DNA/RNA EXTRACTION KIT S WITH MAGNETIC BEAD VIS100230 VISIPURIFY AUTOMATED DNA EXTRACTION KIT	A, B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Medicamed	Romania	CLORURA DE SODIU 1000gr CLORURA FERICA 10% 2ml REACTIV FENILALANINA 5g REACTIV OXIDAZA 5gr SER DE CAL 100ml 34 others SUPLIMENT BRUCELLA SUPLIMENT C.N.A (Stafilococi/Streptococi) SUPLIMENT CAMPYLOBACTER BLASER WANG SUPLIMENT CAMPYLOBACTER BUTZLER SUPLIMENT CAMPYLOBACTER C.T.V.A SUPLIMENT CAMPYLOBACTER CCDA SUPLIMENT CAMPYLOBACTER KARMALI SUPLIMENT CAMPYLOBACTER SKIRROW SUPLIMENT CN (PSEUDOMONAS) SUPLIMENT CRESTERE VITALEX cut 10 fiole SUPLIMENT DE CRESTERE LEGIONELLA BCYE cut 10 fiole SUPLIMENT DE CRESTERE PENTRU CAMPYLOBACTER SUPLIMENT DE CRESTERE PENTRU LEGIONELLA cut 10 fiole SUPLIMENT GARDENERELLA cut 10 fiole SUPLIMENT GLICEROL cut 10 fiole SUPLIMENT HAEMOPHILUS cut 10 fiole SUPLIMENT LCAT cut 10 fiole SUPLIMENT LEGIONELLA BMPA cut 10 fiole SUPLIMENT LEGIONELLA GVPC cut 10 fiole SUPLIMENT LEGIONELLA MWY cut 10 fiole SUPLIMENT LISTERIA FRASER cut 10 fiole SUPLIMENT LISTERIA PALCAM pach 10 fiole SUPLIMENT ONPG 1% cut 10 fiole SUPLIMENT PRESTON CAMPYLOBACTER SUPLIMENT SCHAEDLER cut 10 fiole SUPLIMENT SELECTIV MOD VCC cut 10 fiole SUPLIMENT TELURIT DE POTASIU 1% 100ml SUPLIMENT TELURIT DE POTASIU 3.5% 100ml SUPLIMENT TTC 1 % cutie 5x10ml SUPLIMENT UREE 40% 50ml SUPLIMENT V.C.A.T cut 10 fiole SUPLIMENT V.C.N cut 10 fiole SUPLIMENT VITAMINA K 1% 5 x 5ml SUPLIMENT YERSINIA cut 10 fiole	A IVDR	Website office@medicamed.ro EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rhinovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Listeria Monocytogenes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 35 others Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method) S1006E3 refs Nucleic Acid (DNA/RNA) Extraction or Purification Kit (Magnetic beads method) S1002E-24 Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) S1001E3 refs Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) S10013E3 refs Nucleic acid extraction (DNA) or purification kit(Magnetic beads method) S10012E3 refs Nucleic Acid Extraction-Purification Kit IV-IX3 refs Nucleic Acid Extraction-Purification Kit S10016E3 refs Nucleic Acid Extraction-Purification Kit S10018E3 refs Nucleic Acid Extraction-Purification Kit S50015E3 refs Nucleic Acid Extraction-Purification Kit S50016E3 refs Nucleic Acid Extraction-Purification Kit S5005E3 refs Nucleic Acid Extraction-Purification Kit V-VI3 refs Nucleic Acid Extraction-Purification Kit V-VII S5007E-483 refs Pneumocystis Jiroveci, Cryptococcus Neoformans and Aspergillus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)98/79 Red Blood Cell Lysis Buffer Sample Diluent2 refs Sample Release and Storage Reagent X1009E-24D-2 Sample Release Reagent S1011E2 refs Sample Release Reagent S1012E3 refs Sample Release Reagent S1013E3 refs Sample Release Reagent S1014E3 refs Sample Release Reagent S1015E-243 refs Sample Storage Reagent X X1010E-48-13 refs Sample Storage Reagent X1001E2 refs Sample Storage Reagent X1002E3 refs Sample Storage Reagent X1003E3 refs Sample Storage Reagent X1004E3 refs Sample Storage Reagent X1006E3 refs Sample Storage Reagent XI X1011E-24A-33 refs Vibrio Cholerae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) MBGV/RVFV/CHIKV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Norovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Nucleic acid extraction (DNA/RNA) or purification kit (Magnetic beads method) S10011E2 refs (no longer marketed) Q Fever Rickettsia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed)	A IVDR, 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction) MVD022 refs Coxsackievirus A10 Real Time RT-PCR Kit98/79 Coxsackievirus A6 Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) A Strain Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) Asia 1 Strain Real Time RT-PCR Kit98/79 25 others Foot-and-Mouth Disease Virus (FMDV) O Strain Real Time RT-PCR Kit98/79 Foot-and-Mouth Disease Virus (FMDV) Serotype A22 Real Time RT-PCR Kit98/79 Liferiver AU Nucleic Acid Extraction kit MVR063 refs Liferiver ® Auto AT96S A Extraction Kit2 refs Liferiver ® AutoAT96S C Extraction Kit2 refs Liferiver ® AutoEX16P A Extraction Kit2 refs Liferiver ® AutoEX36 C Extraction Kit2 refs Liferiver ® AutoEX36 D Extraction Kit2 refs Liferiver ® AutoEX36 E Extraction Kit2 refs Liferiver ® AutoEX36 F Extraction Kit2 refs Liferiver® AutoAT96P A Extraction Kit MVR102 refs Liferiver® AutoEX36 A Extraction Kit MVR012 refs Liferiver® AutoEX36 B Extraction Kit MVR092 refs Liferiver® Beads Column A Extraction Kit2 refs Liferiver® Preservation Medium MCS013 refs Liferiver® Preservation Solution ACS013 refs RNA Isolation Kit (Paramagnetic Beads Column)2 refs Vibrio Cholerae O1/O139/CTX Lyo-PCR Kit98/79 Viral DNA/RNA Isolation Kit (Centrifuge Column) LVN01 Viral DNA/RNA Isolation Kit (for Auto-Extraction) MVR183 refs Viral RNA Extraction Kit (for Auto-Extraction) MVR102 refs Viral RNA Extraction Kit (Preloaded for Auto-Extraction) MVR152 refs Viral RNA Extraction Kit MVR092 refs Viral RNA Isolation Kit (Preloaded for Auto-Extraction) MVR012 refs Viral Transport Medium RVR093 refs	A IVDR, 98/79	Website EUDAMED record Report an error
Jiangsu Qitian Gene biotechnology EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	Bacillus anthracis Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Brucella Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）3 refs98/79 Ebola virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 23 others Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Plasmodium Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 RAA Nucleic Acid Amplication Kit2 refs RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 refs RAA Nucleic Acid Amplication Kit(Test Strip Method)2 refs RT-RAA Nucleic Acid Amplication Kit2 refs RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)2 refs RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)2 refs Salmonella Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 SARS-CoV-2 Nucleic Acid Detection Kit98/79 Schistosoma Haematobium Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Schistosoma Mansoni Nucleic Acid Detection Kit（Fluorescent RAA)3 refs98/79 Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 V1-D/R-64JⅠ3 refs V2-D/R-64J3 refs Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Yellow Fever Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Yersinia Pestis Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79 Zika Virus Nucleic Acid Detection Kit（Isothermal Amplification)3 refs98/79	A IVDR, 98/79	Website EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland)	India	TRUPCR® Bacterial / Fungal DNA Extraction Kit2 refs TRUPCR® Bacterial DNA Extraction Kit2 refs TRUPCR® Blood DNA Extraction Kit2 refs TRUPCR® Blood RNA Extraction Kit TRUPCR® BS DNA Extraction Kit 17 others TRUPCR® FFPE Tissue DNA Extraction Kit TRUPCR® Magbead Blood DNA Extraction Kit TRUPCR® Magbead FFPE Tissue DNA Extraction Kit2 refs TRUPCR® Magbead MTB/NTM DNA Extraction Kit2 refs TRUPCR® Magbead Tissue DNA Extraction Kit2 refs TRUPCR® Magbead Total Nucleic Acid Extraction Kit2 refs TRUPCR® Magbead Total Viral Nucleic Acid Extraction Kit2 refs TRUPCR® Magbead Viral RNA Extraction Kit2 refs TRUPCR® MTB/NTM DNA Extraction Kit TRUPCR® Panel Extraction Kit TRUPCR® Respiratory Pathogen Panel Kit3 refs TRUPCR® Tissue DNA Extraction Kit TRUPCR® Total Nucleic Acid Extraction Kit4 refs TRUPCR® Total Nucleic Acid Extraction Kit (500ul) TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)98/79 TRUPCR® Total Nucleic Acid Extraction Kit (500µl) TRUPCR® Total Viral Nucleic Acid Extraction Kit (500µl) TRUPCR® Total Viral Nucleic Acid Extraction Kit2 refs TRUPCR® Viral RNA Extraction Kit2 refs	A, C IVDR, 98/79	Website info@3bblackbio.com EUDAMED record Report an error
Clonit	Italy	Bact Extra Pure Kit EDR004050 CloNext Bacterial DNA Extraction Kit OP02006-48 CloNext Blood DNA Extraction Kit 1200 OP02002-48 CLONEXT BLOOD DNA EXTRACTION KIT 200 OP02001-48 Clonext CF DNA Extraction Kit LV OP02025-48 17 others CloNext CFC DNA Extraction Kit OP02017-48 CLONEXT CULTURED CELL DNA EXTRACTION KIT OP02005-48 CLONEXT FFPE DNA EXTRACTION KIT OP02009-48 CloNext HPV DNA Extraction Kit for Swab Sample OP02007-48 CloNext Plant DNA Extraction Kit OP02014-48 CloNext TB DNA Extraction Kit OP02008-48 CloNext Tissue DNA Extraction Kit OP02004-48 CLONEXT TOTAL RNA EXTRACTION KIT OP02015-48 CloNext Viral Nucleic Acid Extraction Kit LV OP02016-48 CloNext Viral Nucleic Acid Extraction Kit OP02003-48 CloNext Viral RNA Extraction Kit OP02013-48 CLONEXT VIRAL/PATHOGEN NUCLEIC ACID EX KIT A OP02011-48 CLONEXT VIRAL/PATHOGEN NUCLEIC ACID EX KIT B OP02012-48 Duplica BLOOD DNA Kit EDI002250 Duplica NA Body Fluid Kit EDI004200 Fassst DNA Releaser EMR057050 Spin DNA Purification Kit EMR061050	A IVDR	Website info@clonit.it EUDAMED record Report an error
Idilbiotech	Türkiye	DirEXT Nucleic Acid Extraction Reagent3 refs98/79 DirEXT OneStep HPV DNA Extraction Reagent2 refs98/79 DirEXT OneStep Pathogen DNA/RNA Extraction Reagent2 refs98/79 RevoDx Viral DNA Purification Kit3 refs98/79 RevoDx Viral RNA Purification Kit3 refs98/79 17 others RevoDx Atypical pneumonia Pathogen Detection Kit2 refs98/79 RevoDx Cervical Specimens Transport Reagent3 refs98/79 RevoDx DNA Purification Kit from Bacteria3 refs98/79 RevoDx DNA Purification Kit from Blood2 refs98/79 RevoDx DNA Purification Kit from Blood Culture3 refs98/79 RevoDx DNA Purification Kit from Respiratory Samples3 refs98/79 RevoDx DNA Purification Kit from Tissue and Paraffin-Embedded Tissue3 refs98/79 RevoDx GEL/PCR Product Purification Kit3 refs98/79 RevoDx Genomic DNA Purification Kit from Blood98/79 RevoDx Genomic DNA Purification Kit from Yeast2 refs98/79 RevoDx Magnetic Pathogen DNA/RNA Purification Kit3 refs98/79 RevoDx Magnetic Viral Nucleic Acid Purification Kit3 refs98/79 RevoDx Pathogen DNA/RNA Purification Kit3 refs98/79 RevoDx Plasmid DNA Purification Kit3 refs98/79 RevoDx Stool Pathogen DNA/RNA Purification Kit3 refs98/79 RevoDx Viral Nucleic Acid Purification Kit5 refs98/79 RevoDx Viral Transport Medium3 refs98/79	– 98/79	Website EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor™3 refs LyoSens Haemophilus Ducreyi Detection qPCR Kit LYO8198/79 LyoSens™ LYO815WS2498/79 LyoSens™ LYO81WS9698/79 ViraSens Gel Nucleic Acid Purification Kit VIRA08P100 17 others ViraSens Gel Nucleic Acid Purification Kit VIRA08P50 ViraSens Genomic DNA Purification From Bacteria VIRA0450 ViraSens Genomic DNA Purification From Bacteria VIRA04P100 ViraSens Genomic DNA Purification From Blood VIRA02P100 ViraSens Genomic DNA Purification From Blood VIRA02P50 ViraSens Genomic DNA Purification From Tissue VIRA05P100 ViraSens Genomic DNA Purification From Tissue VIRA05P50 ViraSens Plasmid DNA Purification Kit VIRA07P100 ViraSens Plasmid DNA Purification Kit VIRA07P50 ViraSens Total Nucleic Acid Purification Kit VIRA09P100 ViraSens Total Nucleic Acid Purification Kit VIRA09P50 ViraSens Viral DNA Purification Kit VIRA06P100 ViraSens Viral DNA Purification Kit VIRA06P50 ViraSens Viral Nucleic Acid Purification Kit VIRA01P100 ViraSens Viral Nucleic Acid Purification Kit VIRA01P50 ViraSens Viral RNA Purification Kit VIRA03P100 ViraSens Viral RNA Purification Kit VIRA03P50	A, C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Taiwan Advanced Nanotech FDA EU representative : mdi Europa GmbH (Germany)	Taiwan	611 series3 refs 612 series3 refs 615 series3 refs 61C series3 refs 61E series3 refs 16 others 61F series3 refs 61G series3 refs 61H series3 refs 61P series3 refs 621 series3 refs 622 series3 refs 635 series3 refs 63F series3 refs 665 series3 refs 66P-MS series3 refs 685 series3 refs 6K2 series3 refs 6SC series3 refs 6ST series3 refs 6T2 series3 refs 6TF series3 refs	A IVDR	Website EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AccuPrep® Dx Viral RNA Extraction Kit ExiPrep ™ 48 Viral RNA Kit ExiPrep™48 Viral RNA Kit ExiPrep™ 48 Genomic DNA Kit ExiPrep™48 Genomic DNA Kit ExiPrep™ 48 SF Genomic DNA Kit ExiPrep™ 48 SF Mycobacteria Genomic DNA Kit 15 others ExiPrep™ 48 SF Viral DNA/RNA Kit ExiPrep™ 48 Viral DNA/RNA Kit ExiPrep™ 96 Genomic DNA Kit ExiPrep™ 96 Viral DNA/RNA Kit ExiPrep™ Dx Bacteria Genomic DNA Kit ExiPrep™ Dx Blood Genomic DNA Kit ExiPrep™ Dx Blood Viral DNA Kit ExiPrep™ Dx Mycobacteria Genomic DNA Kit ExiPrep™ Dx SF Mycobacteria Genomic DNA Kit ExiPrep™ Dx Viral DNA Kit ExiPrep™ Dx Viral DNA/RNA Kit ExiPrep™ Dx Viral RNA Kit ExiStation™ FA DNA/RNA Kit (V2) ExiStation™ FA DNA/RNA Kit (V3) MagListo™ 5M Viral DNA/RNA Extraction Kit	A IVDR	Website sales@bioneer.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage 48 tests/kit98/79 Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79 Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage 48 tests/kit98/79 Jiangsu Macro & Micro-Test Med-Tech Co., Ltd Type Ⅰ: 50 tests/ kit3 refs 13 others Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Dengue virus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2) 16 tests/kit98/79 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for SARS-CoV-2 16 tests/kit98/79 Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR) 50 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 24 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 25 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 48 tests/kit98/79 Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens 50tests/kit98/79 Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 50 tests/kit98/79 SARS-CoV-2 Variant B.1.617.2 Rapid Identification Kit (Fluorescence PCR) 50 tests/kit98/79 SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) 50 tests/kit98/79	A IVDR, 98/79	marketing@hongweitest.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Bacteria DNA Extraction Kit (Magnetic Bead Method) SDK60108-48T3 refs Cell Nucleic Acid Extraction Kit (Magnetic Bead Method) SDK80125-48T3 refs FFPE DNA Isolation Kit (Magnetic Bead Method)2 refs Genetic-Specific Whole Blood DNA Extraction Kit (Magnetic Bead Method) SDK60128-48T(163)3 refs Monkeypox Virus Real Time PCR Kit YJC70115NW-25T98/79 11 others Monkeypox Virus Real Time PCR Kit YJC70115NW-50T98/79 Nucleic Acid Extraction and Purification Rapid Kit 96T (Magnetic Bead Method) Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method) SDKF60101-32T(162)3 refs Nucleic Acid Extraction Rapid Kit 96T (Magnetic Bead Method) Pathogen DNA/RNA Extraction Kit (Magnetic Bead Method) SDK60120-48T(163)3 refs Sputum DNA Isolation Kit (Boiling Method)2 refs Tissue DNA Isolation Kit (Magnetic Bead Method)3 refs Viral DNA/RNA Extraction Kit (Magnetic Bead Method) SDK60116-48T(163)3 refs Viral Nucleic Acid Extraction Kit (Magnetic Bead Method) SDK60104-32T(162)3 refs Viral Nucleic Acid Isolation Kit (Silica-Based Spin Column) Whole Blood DNA Extraction Kit (Magnetic Bead Method) SDK60110-48T(163)3 refs	A IVDR, 98/79	EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Nucleic Acid Extraction or Purification Kit Bulk Type A: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Bulk Type B: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 20 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 32 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 36 reactions/ kit98/79 11 others Nucleic Acid Extraction or Purification Kit Type A: 40 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 64 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 96 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 20 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 32 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 36 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 40 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 64 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 96 reactions/ kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Vircell	Spain	AMPLIRUN® TOTAL CT/NG CONTROL (EXUDATE) MBTC00698/79 AMPLIRUN® TOTAL CT/NG CONTROL (URINE) MBTC00398/79 AMPLIRUN® TOTAL FLU A/FLU B/RSV CONTROL (SWAB) MBTC02898/79 AMPLIRUN® TOTAL GASTROINTESTINAL BACTERIAL PANEL CONTROL (STOOL) MBTC02198/79 AMPLIRUN® TOTAL HSV-1/HSV-2/VZV CONTROL (EXUDATE) MBTC01698/79 11 others AMPLIRUN® TOTAL MACROLIDE RESISTANT MGE CONTROL PANEL (SWAB) MBTC02998/79 AMPLIRUN® TOTAL MDR-TB VERIFICATION & CONTROL PANEL MBTC02798/79 AMPLIRUN® TOTAL MTB CONTROL (SPUTUM) MBTC01398/79 AMPLIRUN® TOTAL MTB INH RESISTANT CONTROL (SPUTUM) MBTC01598/79 AMPLIRUN® TOTAL MTB RIF RESISTANT CONTROL (SPUTUM) MBTC01498/79 AMPLIRUN® TOTAL RESPIRATORY VIRAL PANEL CONTROL (SWAB) MBTC02098/79 AMPLIRUN® TOTAL SARS-CoV-2 CONTROL (SWAB) MBTC03098/79 AMPLIRUN® TOTAL SARS-CoV-2/FluA/FluB/RSV CONTROL (SWAB) MBTC03198/79 AMPLIRUN® TOTAL ZIKV/DENV/CHIKV CONTROL (PLASMA) MBTC02398/79 Vircell S.L SE002 VIRCLIA® EXTRACTION SOLUTION VCES001	A IVDR, 98/79	EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks16 refs Anatolia Geneworks Bosphore Bacterial DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore COVID-19 Sampling and Viral RNA Extraction Kit Anatolia Geneworks Bosphore Genomic DNA Extraction Spin Kit v2 Anatolia Geneworks Bosphore Tissue Genomic DNA Extraction Spin Kit v2 9 others Anatolia Geneworks Magnesia 2448 Bacterial DNA Extraction Kit Anatolia Geneworks Magnesia 2448 Viral DNA/RNA Extraction Kit Anatolia Geneworks Magnesia 2448 Viral DNA/RNA Extraction Kit EP2 refs Anatolia Geneworks Magnesia 2448 Whole Blood Genomic DNA Extraction Kit Anatolia Geneworks UNIO 96 Nucleic Acid Extraction Versatile Kit MG92 refs Anatolia Geneworks Unio 96 Nucleic Acid Extraction Versatile Kit Anatolia Geneworks Unio M32 Viral DNA/RNA Extraction Kit2 refs Anatolia Geneworks UNIO M32 Viral Nucleic Acid Extraction TB Anatolia Geneworks Unio Viral DNA/RNA Extraction Kit 600 µl2 refs	A IVDR	Website info@anatoliagenetik.com EUDAMED record Report an error
Hain Lifescience	Germany	FluoroLyse VER 1.0 GenoLyse VER 1.0 GXT Blood Extraction Kit VER 2.0 GXT NA Extraction Kit VER 1.0 GXT96 X2 Extraction Kit VER 1.0 9 others GXT96 X3 Extraction Kit VER 1.0 Inactivation Set VER 1.0 Liquefaction Set VER 1.0 Proteinase K Set VER 1.0 Reagent Set for DNA•STRIP Kits SpheroLyse VER 1.0 Stool Buffer VER 1.0 SW Set VER 1.0 X2 Cartridge VER 1.0	A IVDR	EUDAMED record Report an error
Norgen Biotek EU representative : Emergo Europe B.V. (Netherlands)	Canada	Blood Genomic DNA Isolation Mini Kit Dx FFPE DNA Purification Kit Dx FFPE RNA Purification Kit Dx FFPE RNA/DNA Purification Plis Kit Plasma/Serum Cell-Free Circulating Purification Kit Dx3 refs 9 others Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format) Plasma/Serum Circulating DNA Purification Mini Kit Dx (Slurry Format) Saliva DNA Isolation Kit Dx Saliva/Swab RNA Purification Kit Dx2 refs Stool DNA Isolation Kit Dx Stool Total RNA Purification Kit Dx Total RNA Purification Kit Dx3 refs Urine DNA Isolation Kit Dx Urine Total RNA Purification Maxi Kit Dx (Slurry Format)	A IVDR	Website regulatory@norgenbiotek.com EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Biospin Omni Genomic DNA Extraction Kit BSC39S1, BSC39M12 refs Biospin Virus DNA/RNA Extraction Kit BSC77S1, BSC77M1, BSC77L13 refs MagaBio FFPE Tissue Genomic DNA Purification Kit BSC31S1, BSC31M1, BSC31M1S, BSC31N1E, BSC31T1S, BSC31S1S, BSC31M1E, BSC31L1E, BSC31T1E, BSC31S1E, BSC31T1C, BSC31S1C, BSC31M1E-T, BSC31L1E-T, BSC31T1C-C, BSC31S1C-C, BSC31S1P-A3 refs MagaBio FFPE Tissue Genomic DNA/RNA Purification Kit BSC118T1S, BSC118S1S, BSC118M1S, BSC118N1E, BSC118T1E, BSC118S1E, BSC118M1E, BSC118L1E, BSC118T1C-C, BSC118S1C-C, BSC118M1E-T, BSC118L1E-T, BSC118S1B, BSC118M1B, BSC118S1P-A3 refs MagaBio FFPE Tissue RNA Purification Kit BSC36S1, BSC36M1, BSC36M1S, BSC36N1E, BSC36T1S, BSC36S1S, BSC36M1E, BSC36L1E, BSC36T1E, BSC36S1E, BSC36M1E-T, BSC36L1E-T, BSC36T1C-C,BSC36S1C-C, BSC36S1P-A3 refs 8 others MagaBio plus General Genomic DNA Purification Kit Ⅱ BSC74S1B, BSC74M1B, BSC74M1S, BSC74N1E, BSC74T1S, BSC74S1S, BSC74M1E, BSC74L1E, BSC74T1E, BSC74S1E, BSC74T1C, BSC74S1C, BSC74M1E-T, BSC74L1E-T, BSC74T1C-C, BSC74S1C-C, BSC74S1P-A3 refs MagaBio plus Virus DNA / RNA Purification Kit Ⅱ BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T3 refs MagaBio plus Virus DNA /RNA Purification Kit VI BSC110S1B, BSC110M1B, BSC110T1S, BSC110S1S, BSC110M1S, BSC110N1E, BSC110T1E, BSC110S1E, BSC110M1E, BSC110L1E, BSC110T1P, BSC110S1P, BSC110M1E-T, BSC110L1E-T, BSC110T1C, BSC110S1C, BSC110T1C-C, BSC110S1C-C, BSC110S1P-A3 refs MagaBio plus Virus RNA Purification Kit Ⅱ BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P3 refs MagaBio plus Whole Blood Genomic DNA Purification Kit BSC08S1B, BSC08M1B, BSC08T1P, BSC08S1P, BSC08T1S, BSC08S1S, BSC08M1S, BSC08T1E, BSC08S1E, BSC08M1E, BSC08L1E, BSC08T1C, BSC08S1C, BSC08M1E-T, BSC08L1E-T, BSC08T1C-C, BSC08S1C-C, BSC08N1E, BSC08S1P-A3 refs MagaBio plus Whole Blood Genomic DNA Purification Kit II BSC73S1B, BSC73M1B, BSC73T1P, BSC73S1P, BSC73T1S, BSC73S1S, BSC73M1S, BSC73L1E, BSC73T1E, BSC73S1E BSC73M1E, BSC73N1E, BSC73S1P-A, BSC73T1C, BSC73S1C, BSC73M1E-T, BSC73L1E-T, BSC73T1C-C, BSC73S1C-C3 refs MagaBio plus Whole Blood Total RNA Purification Kit II BSC133S1B, BSC133M1B, BSC133T1S, BSC133S1S, BSC133T1E, BSC133S1E, BSC133M1S, BSC133N1E, BSC133T1C, BSC133S1P-A, BSC133M1E, BSC133L1E, BSC133S1C, BSC133T1C-C, BSC133M1E-T, BSC133L1E-T, BSC133S1C-C3 refs Simply P Virus DNA/RNA Extraction Kit BSC67S1, BSC67M1, BSC67L13 refs	A IVDR	Website ra_oversea@bioer.com.cn EUDAMED record Report an error
DNA-Technology, Research & Production EU representative : Obelis s.a. (Belgium)	Russia	PREP-CITO DBS DNA Extraction Kit, Package N PREP-GS DNA Extraction Kit3 refs PREP-MB DWP DNA/RNA Extraction Kit, Package A3 refs PREP-MB MAX DNA Extraction Kit, Package A2 refs PREP-MB-DBS DWP DNA Extraction Kit, package N3 refs 7 others PREP-MB-RAPID II DNA Extraction Kit, Package A3 refs PREP-NA DNA/RNA Extraction Kit3 refs PREP-NA-FET DNA Extraction Kit PREP-NA-S DNA/RNA Extraction Kit PREP-OPTIMA DNA Extraction Kit. Package N3 refs PREP-PK Kit for sample pretreatment while processing of nucleic acids isolation, Set № 12 refs PREP-RAPID DNA Extraction Kit2 refs	A IVDR	Website EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	"AHTV01-AHG48E， AHTV01-AHG96E"98/79 ADZCOM01D-AHG48E98/79 AHTV01D-AHG48E98/79 CMTB01A-AHG4E98/79 CMTBMDR01A-AHG4E98/79 7 others CMTBMDRZK01-AHG4E98/79 CMTBRIF01A-AHG4E98/79 CMTBRIFZK01-AHG4E98/79 SCLS01-AHG10E98/79 SNCE01-AHG48/ SNCE01-AHG96/ SNCE02-AHG16/ SNCE02-AHG48/ SNCE02-AHG9698/79 SNCE05-AHG48E98/79 SNCE07-AHG50E98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STARMag 96 ProPrep2 refs STARMag 96 ProPrep C2 refs STARMag 96 ProPrep plus2 refs STARMag 96 x 4 UniVersal Cartridge Kit STARMag 96 x 4 UniVersal plus Cartridge Kit 7 others STARMag 96 x 4 Viral DNA/RNA 200 C Kit STARMag™ M96 Kit2 refs STARMag™ N/S Kit STARMag™ S96H Kit3 refs STARMag™ S96H N Kit2 refs STARMag™ SP32 Kit2 refs STARprep™ EZ Buffer2 refs	A IVDR	Website info@seegene.com EUDAMED record Report an error
Qiagen FDA	Germany	EZ1 DSP DNA Blood Kit EZ1 DSP Virus Kit QIAamp DSP DNA Blood Mini Kit QIAamp DSP DNA FFPE Tissue Kit QIAamp DSP Virus Kit 6 others QIAamp DSP Virus Spin Kit QIAsymphony DSP DNA Midi Kit2 refs QIAsymphony DSP DNA Virus/Pathogen Midi Kit2 refs RNeasy DSP FFPE Kit RNeasy DSP Midi Kit RNeasy DSP MinElute Cleanup Kit	A IVDR	Website info@qiagen.com EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	Nucleic Acid Extraction Reagent Human Whole Blood DNA (Spin-Column) Nucleic Acid Extraction Reagent MCP-16C, MCP-96C, MCP-100F, MCP-96E Nucleic Acid Extraction Reagent MEB-16C, MEB-96C, MEB-100F, MEB-16D, MEB-96D Nucleic Acid Extraction Reagent MEG-16C, MEG-96C, MEG-100F Nucleic Acid Extraction Reagent MES-16C, MES-96C, MES-100F 6 others Nucleic Acid Extraction Reagent MNP-16C, MNP-96C, MNP-100F, MNP-96E Nucleic Acid Extraction Reagent MNS-16C; MNS-48F Nucleic Acid Extraction Reagent Pathogen DNA (Spin-Column) Nucleic Acid Extraction Reagent QIA Sample Pretreatment Kit for DNA Methylation Test BS Sample Pretreatment Kit for DNA Methylation Test MBS-16C; MBS-48F	A IVDR	Website EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	302011 302012 302013 302014 800814 5 others 800827 800841 800941 800945 800971	A IVDR	Website EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other	China	DNA Extraction Kit (Lab-Aid 896)3 refs Respiratory Pathogen Panel (RPP3D)98/79 Respiratory Pathogen Panel (RPP40D)98/79 Respiratory Pathogen Panel (RPP4D)98/79 Sanity-2 Respiratory Pathogen Panel (RPP22)98/79 5 others Sanity-2 Respiratory Pathogen Panel (RPP3)98/79 Sanity-2 Respiratory Pathogen Panel (RPP4)98/79 Sanity-2 Respiratory Pathogen Panel (RPP40)98/79 SARS-CoV-2 Test Kit98/79 SARS-CoV-2 Test Kit (Sanity 2.0)4 refs98/79	A IVDR, 98/79	info@zsandx.com EUDAMED record Report an error
ALS Life Sciences Portugal	Portugal	InviMag® Blood DNA Mini Kit/ IG InviMag® Universal Kit/ IG InviMag® Universal Kit/ KF962 refs InviSorb® Spin Blood Mini Kit (250)2 refs InviSorb® Spin Universal Kit (250)2 refs 4 others InviTrap® Spin Universal RNA Mini Kit (250)2 refs PSP® SalivaGene DNA Kit (250)2 refs PSP® Spin Stool DNA Basic Kit (250)2 refs RTP® Pathogen Kit (250)2 refs	A IVDR	Website EUDAMED record Report an error
Ecolidx	Czechia	ePure Bacterial DNA Extraction Kit ePure Blood DNA Extraction Kit 200 ePure CFC DNA Extraction Kit ePure FFPE DNA Extraction Kit ePure Forensic DNA Extraction Kit 4 others ePure STD DNA Extraction Kit ePure TB DNA Extraction Kit ePure Tissue DNA Extraction Kit ePure Viral Nucleic Acid Extraction Kit	A IVDR	Website EUDAMED record Report an error
Hybribio EU representative : Kingsmead Service B.V. (Netherlands)	China	1 mL/tube, 24 tubes/box; 1 mL/tube, 48 tubes/box; 1 mL/tube, 96tubes/box; 2 mL/tube, 47tubes/box; 2 mL/tube, 48tubes/box; 2 mL/tube, 96 tubes/box; 3 mL/tube, 48 tubes/box; 3 mL/tube, 96 tubes/box 16 Tests/ Kit, 32 Tests/ Kit, 48 Tests/ Kit, 128 Tests/ Kit, 160 Tests/ Kit, 192 Tests/ Kit3 refs 16 Tests/ Kit, 48 Tests/ Kit 16 Tests/Kit, 32 Tests/Kit, 48 Tests/Kit, 128Tests/Kit, 160 Tests/Kit, 192 Tests/Kit3 refs 30 Tests/ Kit, 24 Tests/ Kit, 6 Tests/ Kit 4 others 48 Tests/Kit 50 tests/kit 6 Tests/Kit，30 Tests/Ki HBMP-R/96: 16 Tests/ Kit, 96 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9600-T1: 16 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9601: 16 Tests/ Kit, 192 Tests/ Kit3 refs	A IVDR	EUDAMED record Report an error
Sentinel FDA	Italy	SENTiNAT® 200 Pathomag Extraction Kit SENTiNAT® X48 Pathomag Extraction kit STAT-NAT® DNA Mix STAT-NAT® DNA Mix Flex STAT-NAT® DNA/RNA Pathogen extraction kit 4 others STAT-NAT® Pathomag extraction kit STAT-NAT® RNA Mix STAT-NAT® SN200 DNA Mix STAT-NAT® Total DNA/RNA extraction kit	A IVDR	Website EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi	Türkiye	Eye Infection Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (24)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (48)3 refs98/79 Gastrointestinal Detection and Monitoring Kit (96)3 refs98/79 Monkeypox Virus Detection and Monitoring Kit (24)3 refs98/79 3 others Sapovirus Detection and Monitoring Kit (24)3 refs98/79 Sapovirus Detection and Monitoring Kit (48)3 refs98/79 Urinary Tract Infection Detection and Monitoring Kit (24)3 refs98/79	– 98/79	Website EUDAMED record Report an error
Geneproof	Czechia	croBEE 101A Whole Blood DNA Extraction Kit croBEE 2.0 Universal Nucleic Acid Extraction Kit croBEE 201A Nucleic Acid Extraction Kit GeneProof Blood Pretreatment Sample Tube2 refs GeneProof PathogenFree DNA Isolation Kit 3 others GeneProof PathogenFree RNA Isolation Kit GeneProof Urine Pretreatment Sample Tube2 refs myCROBE/croBEE 2.0 Universal Extraction Kit	A IVDR	Website support@geneproof.com EUDAMED record Report an error
Laboveritas	Latvia	Express Genetics DNA 0018 ExtraMag 1000 0020 Laboveritas 475104263LVE00156T VeriLab Express DNA 0014 VeriLab ExtraMag 500 0019 3 others Verilab GMag 0012 VeriLab UMag Verilab USorb 0011	A IVDR	Website EUDAMED record Report an error
Beaverbio EU representative : Kingsmead Service B.V. (Netherlands)	China	BeaverBeads™ Blood DNA Kit 70423 BeaverBeads™ Circulating DNA Kit 70404 BeaverBeads™ Multi Sample RNA Kit 70418 BeaverBeads™ Saliva DNA Kit 70405 BeaverBeads™ Stool DNARNA Kit 70411 2 others BeaverBeads™ Viral DNA RNA Kit 70406 BEAVER™ Cell Free DNA Tubes 43803	A IVDR	sales@beaverbio.com EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	Sentosa SX Lysis Beads 300291 Sentosa SX Lysis Plate (10x96) 300649, 3007042 refs Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) 300042 Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16) 300351 Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) 300154 2 others Sentosa SX Whole Blood Kit (4x24) 300252 ViroKey HT Virus Total Nucleic Acid Kit (4x96) 300678, 3010892 refs	A IVDR	Website infoAPAC@veladx.com EUDAMED record Report an error
Xi'An Huawei Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	Bacteria Genomic DNA Purification Kit 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 refs Blood Genomic DNA Purification Kit 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 refs HPV Genomic DNA Purification Kit 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 refs Magnetic Bead DNA/RNA Purification Kit 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (Pre-filled), 5T/Plate × 4plates 64T/Box (Pre-filled), 16T/Plate × 4plates3 refs Magnetic Bead DNA/RNA Purification Kit 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips 64T/Box (Pre-filled), 16T/Plate × 4plates 40T/Box (Pre-filled), 10T/Plate × 4plates 20T/Box (Pre-filled), 5T/Plate × 4plates3 refs 2 others Magnetic Bead DNA/RNA Purification Kit 64T/Box (Pre-filled), 16T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips2 refs Magnetic Bead DNA/RNA Purification Kit 64T/Box (Pre-filled), 16T/Plate × 4plates 32T/Box (Pre-filled), 8T/Plate × 4plates 20T/Box (DT6) (Pre-filled), 1T/Strip × 20strips3 refs	A IVDR	EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Promotor Nucleic Acid (DNA) Extraction Kit3 refs Promotor Nucleic Acid (RNA) Extraction Kit3 refs Promotor Nucleic Acid Extraction Kit Promotor Viral DNA/RNA Isolation Kit2 refs Promotor Viral Nucleic Acid Isolation Kit 1 other Promotor Whole Blood Genomic DNA Extraction Kit2 refs	A IVDR	Website EUDAMED record Report an error
Astra Biotech	Germany	Magnetic DNA / RNA Auto Extraction kit Magnetic DNA/RNA Auto Extraction kit (Form P1) Magnetic Plus DNA/RNA Auto Extraction kit Magnetic Plus DNA/RNA Auto Extraction kit (Form P1) Multi DNA Extraction kit 1 other Prime DNA/RNA Extraction kit	A IVDR	Website info@astrabiotech.de EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Bacterial DNA Extraction Kit Nucleic Acid Extraction Kit CN8033 Nucleic Acid Extraction Kit CN8043 Sample Release Reagent B2150 Sample Release Reagent CN8063 1 other Sample Release Reagent CN8073	A IVDR	EUDAMED record Report an error
bioMérieux FDA	France	NUCLISENS® easyMAG® Extraction Buffer 1 NUCLISENS® easyMAG® Extraction Buffer 2 NUCLISENS® easyMAG® Extraction Buffer 3 NUCLISENS® easyMAG® Lysis Buffer NUCLISENS® easyMAG® Magnetic Silica 1 other NUCLISENS® Lysis Buffer	A IVDR	EUDAMED record Report an error
altona Diagnostics FDA	Germany	AltoStar® Purification Kit 1.5 AltoStar® Respiratory Sample Pretreatment Buffer 1.5 AltoStar® Whole Blood Pretreatment Buffer 1.5 ExtraStar® Purification Kit 2.0 FlexStar® (RT-)PCR Amplification Mix 1.52 refs	A IVDR	info@altona-diagnostics.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	MagNXT FFPE DNA Extraction Kit G2M8100073 refs MagNXT Tissue & body fluids Nucleic acid extraction kit G2M2121213 refs SpiNXT Cell free DNA Extraction Kit G2M8100132 refs SpiNXT FFPE DNA Extraction Kit G2M2321212 refs SpiNXT Tissue & body fluids Nucleic acid extraction kit G2M1314202 refs	A IVDR	Website EUDAMED record Report an error
Katsura EU representative : Kingsmead Service B.V. (Netherlands)	Taiwan	Katsura Biological Coporation 310111 Katsura Biological Coporation 310211 Katsura Biological Coporation 310311 Katsura Biological Coporation 320211 Katsura Biological Coporation 320311	A IVDR	Website EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	32T/Kit 48T/Kit 64T/Kit 8T/Kit 96T/Kit	A IVDR	Website EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium)	India	STABILYSE Prep Free 90101PF05, 90101PF20, 90101PF25, 90101PF503 refs Trueprep AUTO MTB Sample Pre-treatment Pack 60204AS05, 60204AS20, 60204AS25, 60204AS503 refs Trueprep AUTO Universal Cartridge Based Sample Prep Kit 60203AR25, 60203AR502 refs Trueprep AUTO Universal Sample Pre-treatment Pack 60205AB05, 60205AB20, 60205AB25, 60205AB503 refs Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Kit 60207AR50	A IVDR	Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	64 Tests/kit 64Test/Kit3 refs 64Tests/kit2 refs 96A Automated Viral DNA/RNA Isolation Kit2 refs	A IVDR	EUDAMED record Report an error
Ab Analitica	Italy	GENEQUALITY 2050 Extraction C GENEQUALITY 2050 Extraction P GENEQUALITY X120 PATHOGEN KIT IC 05-79-A2 refs	A IVDR	customersupport@abanalitica.it EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	United States	Alinity m7 refs ALINITY M SAMPLE PREP 1 ALINITY M SAMPLE PREP 2 RealTime4 refs	A IVDR	EUDAMED record Report an error
Bgi	Denmark	BGI 32tests BGI 48 tests BGI 50 tests/kit98/79 Nucleic Acid Extraction Kit 96 tests	A IVDR, 98/79	Website EUDAMED record Report an error
Genfine EU representative : MedPath GmbH (Germany)	China	DNA/RNA Extraction Kit(Column) D102：200preps/box3 refs DNA/RNA Extraction Kit(Magnetic Beads) 101-B: 25preps/box3 refs Virus DNA/RNA Kit(Column) D501:200preps/box3 refs Virus DNA/RNA Kit(Magnetic Beads) 502-B: 480preps/box3 refs	A IVDR	EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands)	China	Human Leukocyte Antigen B27 Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 Nucleic Acid Extraction Kit (Boiling Method)3 refs Nucleic Acid Extraction Kit (Spin Column)3 refs Nucleic Acid Extraction Kit P01911P20643 refs	A IVDR, 98/79	EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerPrep™ Pathogen NA Extraction Kit EXP2 refs PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 PowerPrep™ Viral NA Extraction Kit EXP2 refs PowerPrep™ Whole blood NA Extraction Kit EXP2 refs	A IVDR	Website info@kogene.co.kr EUDAMED record Report an error
MagBio Genomics FDA EU representative : CEpartner4U (Netherlands)	United States	HighPrep Viral DNA & RNA Kit - DX (20 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (384 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (3840 preps) Kit for viral RNA and DNA isolation HighPrep Viral DNA & RNA Kit - DX (96 preps) Kit for viral RNA and DNA isolation	A IVDR	Website info@magbiogenomics.com EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain)	China	Digital PCR Universal Kit dPCR Nucleic Acid Extraction or Purification Reagent CF12 refs Nucleic Acid Extraction or Purification Reagent Easy-CF2 Nucleic Acid Extraction or Purification Reagent TF1	A IVDR	EUDAMED record Report an error
RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi	Türkiye	RTA MB VIRAL NUCLEIC ACID ISOLATION KIT (12 Tests) 12 Tests/ Kit, 24 Tests/ Kit, 48 Tests/ Kit3 refs RTA TOTAL NUCLEIC ACID EXTRACTION KIT 16 Tests/ Kit, 48 Tests/ Kit, 96 Tests/ Kit3 refs RTA VIRAL NUCLEIC ACID ISOLATION KIT (100 TESTS) 50 tests/ kit, 100 tests/ kit2 refs RTA VIRAL RNA ISOLATION KIT (100 TESTS) 50 Tests, 100 Tests2 refs	A IVDR	Website EUDAMED record Report an error
Yzymedical EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	ATM/p53/13q14/RB1/CSP12 gene Probe Detection Kit (fluorescence in situ hybridization )98/79 HER-2 DNA Probe Kit (fluorescence in situ hybridization )98/79 i(17q) gene Probe Detection Kit (fluorescence in situ hybridization )98/79 PML/RARA Gene Fusion Probe Detection Kit (fluorescence in situ hybridization )98/79	– 98/79	EUDAMED record Report an error
Zymo Research FDA EU representative : DAVID Catherine Elisabeth Marie (France)	United States	EZ DNA Methylation-Lightning Kit (200 rxns) D5030-E3 refs Quick-DNA-RNA™ HT - Dx (1000 preps) R2140-E3 refs ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack) D4302-E3 refs EZ-96 DNA Methylation-Lightning Kit (Deep-Well) - 2 x 96 Rxns D5033-E (no longer marketed) EZ-96 DNA Methylation-Lightning Kit (Shallow-Well) -2 x 96 Rxns D5032-E (no longer marketed)	A IVDR	info@zymoresearch.com EUDAMED record Report an error
AusDiagnostics EU representative : R-Biopharm AG (Germany)	Australia	Demi DNA Reagent Cassette3 refs Extraction Control MT-Prep Blood DNA Extraction kit 1200 (48 samples)3 refs	A IVDR	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Avioq Bio-tech EU representative : SUNGO Europe B.V. (Netherlands)	China	24 Tests/Kit98/79 48 Tests/Kit98/79 96 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
CleanNA	Netherlands	Clean cell free DNA kit CCF-D0384 Clean Quick Viral2 refs CleanNGS Dx2 refs	A IVDR	Website info@cleanna.com EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene DNA/RNA Extraction Kit Cowingene Sample Release Reagent Cowingene Viral DNA/RNA Column2 refs	A IVDR	Website EUDAMED record Report an error
gerbion	Germany	NukEx Mag RNA/DNA3 refs NukEx Pure RNA/DNA2 refs NukEx Virus	A IVDR	info@gerbion.com EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SNCE01-ADW48,SNCE01-ADW9698/79 SNCE05-ADW4898/79 SNCE07-ADW50E98/79	– 98/79	ra.danwei@danwei-bio.com EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CWX101S/CWX101M2 refs CWX102S/CWX103S/CWX103S-BR/CWX103S-ZY/CWX103S-SLD/CWX104S/CWX104S-BR/CWX104S-ZY/CWX104S-M3 refs CWX112S	A IVDR	EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	SNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG9698/79 SNCE05-BOG48E98/79 SNCE07-AOG50E98/79	– 98/79	EUDAMED record Report an error
Roboscreen	Germany	INSTANT Virus RNA/DNA Kit2 refs INSTANT Virus RNA/DNA Kit - FX3 refs Rapid INSTANT Virus RNA/DNA Kit – FX	A IVDR	Website info@roboscreen.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Nucleic Acid Extraction Reagents(Magnetic Bead) T-16,T-32,T-48,T-64,T-96,T-200,T-9603 refs Nucleic Acid Extraction Reagents(Magnetic Bead) TM-363 refs Nucleic Acid Releaser (For PCR) SR05050, SR10050, SR05080, SR10080,SR05100, SR10100, SR50001, SR100001, SR5L01, SR20L01	A IVDR	sales@singuway.com EUDAMED record Report an error
Transgen EU representative : Kingsmead Service B.V. (Netherlands)	China	EasyPure® Viral DNA/ RNA Kit ER201 MagicPure® 96 Viral DNA/RNA Kit EC301-96 MagicPure® 32 Viral DNA/RNA Kit EC301-32	A IVDR	EUDAMED record Report an error
Vazyme EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	DNA/RNA Extraction Kit RM301-013 refs High-throughput Virus DNA/RNA Nucleic Acid Extraction Kit RM502ME Universal DNA/RNA Extraction Kit ECM01ME-01	A IVDR	EUDAMED record Report an error
Wuhan MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HPV DNA Extraction Kit HD01T-96 Nucleic Acid Extraction Kit BDT-864 T-1728, T-96, OP02-32, VDR03P-32, VDR02P-96, VDR03P-96, SD01T-96, SD01T-1536, FDP-32, CDP-32, CDT-192, CDT-25, CDT-48, CDT-50, BDT-864, BDT-96, MD01T-96, WDT-96, WDT-8643 refs Sample Collection and Release Reagent SCR-100	A IVDR	EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands)	China	Cell-free DNA Extraction Kit (Magnetic Bead Method)3 refs Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.00.B2.083 refs Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.08.B2.083 refs	A IVDR	PMS@zy-ivd.com EUDAMED record Report an error
AD Nucleis	France	Extraction and purification kit of NA for blood 14R IVD3 refs Open lyophilized One-Step qPCR Kit IVD	A IVDR	Website EUDAMED record Report an error
Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	Laborant Omicron VariAnt RT-qPCR Kit Laborant SARS-CoV-2 RT-qPCR Kit	A IVDR	Website info@antmedical.com EUDAMED record Report an error
AO Vector-Best EU representative : BIORON GmbH (Germany)	Russia	RealBest DNA-express RealBest UniMag Universal NA Extraction Kit2 refs	A IVDR	Website EUDAMED record Report an error
Beijing Healthgene Laboratory EU representative : Lotus NL B.V. (Netherlands)	China	20 Tests/Kit98/79 COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Biobase FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Nucleic Acid Extraction Kit II (Magnetic Beads Method) KY002 Nucleic Acid Extraction Kit (Magnetic Beads Method) 16 tests / box（121001）3 refs	A IVDR	EUDAMED record Report an error
Biodetect EU representative : Lotus NL B.V. (Netherlands)	China	2019-nCoV Molecular Diagnostic Kit(Fluorescent PCR Test)98/79 Monkeypox Virus Molecular Diagnostic Kit (Fluorescent PCR Test) (Lyophilized)98/79	– 98/79	Website EUDAMED record Report an error
Bruker FDA	Germany	Micro-Dx2 refs98/79 SepsiTest-UMD2 refs98/79	– 98/79	Website info.md@bruker.com EUDAMED record Report an error
Chengdu Find Medical Devices EU representative : MedPath GmbH (Germany)	China	Cell-Free Fetal DNA Library Prepare Kit Nucleic acid extraction or purification reagent N001	A IVDR	EUDAMED record Report an error
DiagCor Life Science EU representative : SUNGO Europe B.V. (Netherlands)	Hong Kong SAR China	92031 92033	A IVDR	QARA@diagcorlifescience.com EUDAMED record Report an error
Genesystem FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Media:DirectTM Extraction Buffer Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit2 refs	A IVDR	Website ra@genesystem.co.kr EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Germany	PoET Extraction PoET Prep Reagent	A IVDR	Website info@gfeblut.de EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Nucleic Acid Extraction and Purification Kit (Magnetic Bead Method) Q012-96 QA Nucleic Acid Extraction Kit(Magnetic Bead Method)3 refs	A IVDR	EUDAMED record Report an error
Kingcreate EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Pathogen Nucleic Acid Extraction Kit 2×16 tests/kit Type A: 100 tests/kit Type B: 24 tests/kit Type B: 48 tests/kit Type B: 96 tests/kit Type C: 96 tests/kit Type D: 6×16 tests/kit3 refs	A IVDR	EUDAMED record Report an error
Lybe Scientific	Norway	NAxtra®3 refs NAxtra® 2.0 nucleic acid extraction kit3 refs	A IVDR	Website contact@lybescientific.com EUDAMED record Report an error
PreAnalytiX FDA EU representative : QIAGEN GmbH (Germany)	Switzerland	PAXgene Blood RNA Kit QIAsymphony PAXgene Blood ccfDNA Kit	A IVDR	Website EUDAMED record Report an error
Precision System Science FDA EU representative : Emergo Europe B.V. (Netherlands)	Japan	MagDEA Dx MV Ⅱ MagDEA Dx SV	A IVDR	service@pss.co.jp EUDAMED record Report an error
Promega FDA EU representative : Abbott GmbH (Germany)	United States	Abbott mSample Preparation System 04J70-24 Abbott mSample Preparation SystemDNA 06K12-24	A IVDR	EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany)	China	Disposable Virus Sampling Tube2 refs Nucleic Acid Extraction Kit BH002	A IVDR	EUDAMED record Report an error
Shanghai Kehua Bio-engineering EU representative : QbD RepS BV (Belgium)	China	Nucleic Acid Extraction Kit 32 Nucleic Acid Extraction Kit 962 refs Nucleic Acid Extraction Kit KH-G-M-565-48-CE	A IVDR	EUDAMED record Report an error
Shenzhen Uni-medica Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Uni-medica 64T, 96T, 384T, 100T, 300T, 1000T, 4800T2 refs Uni-medica TypeB 100 tests/kit	A IVDR	Website marketing@uni-medica.com EUDAMED record Report an error
Thermofisher FDA	Lithuania	MagMax Dx Viral/Pathogen NA Isolation Kit (A52735, A52736)2 refs MagMax Viral/Pathogen II Nucleic Acid Isolation Kit A48383	A IVDR	info.baltics@thermofisher.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)98/79 EasyNAT Vibrio Cholerae Assay98/79	– 98/79	Website service@bioustar.com EUDAMED record Report an error
Xiamen Sciendox Biological Technology EU representative : MedPath GmbH (Germany)	China	Sciendox ® Extraction Kit for Faecal Nucleic Acid (DNA) Sciendox ® Nucleic acid conversion and purification reagent	A IVDR	EUDAMED record Report an error
Adaltis	Italy	MOLgen Universal Extraction Kit98/79	– 98/79	Website info@adaltis.net EUDAMED record Report an error
Allsheng FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Nucleic acid Extraction and Purification Kit	A IVDR	EUDAMED record Report an error
Appolon Bioteck	France	ABility Smart Extract2 refs	A IVDR	Website contact@appolonbioteck.com EUDAMED record Report an error
Beijing OriginPoly Bio-Tec EU representative : SUNGO Europe B.V. (Netherlands)	China	(12 tests), (24 tests), (48 tests)3 refs	A IVDR	EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany)	China	Nucleic Acid Extraction Kit ZD001	A IVDR	EUDAMED record Report an error
Bioteke FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-53 refs	A IVDR	Website info@bioteke.cn EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden)	United States	Xpert®	A IVDR	Website EUDAMED record Report an error
Cerca Biotech	Germany	RNXtract Kit	A IVDR	EUDAMED record Report an error
Certest	Spain	VIASURE Viral Meningitis Panel Real Time PCR Detection Kit3 refs	C IVDR	Website quality@certest.es EUDAMED record Report an error
Credence Genomics EU representative : Obelis s.a. (Belgium)	Sri Lanka	Bactfast CGNBF001	A IVDR	Website EUDAMED record Report an error
Cyanagen	Italy	STAR BEADS PATHOGEN DNA/RNA EXTRACTION KIT	A IVDR	Website EUDAMED record Report an error
Delbio EU representative : Emergo Europe B.V. (Netherlands)	Taiwan	DELBIO GS1 Nucleic Acid Extraction Kit3 refs	A IVDR	Website EUDAMED record Report an error
Diagre EU representative : SUNGO Europe B.V. (Netherlands)	China	DR-ZTQ001-50 DR-ZTQ001-1002 refs	A IVDR	EUDAMED record Report an error
Eiken FDA EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany)	Japan	Loopamp(TM) PURE DNA Extraction Kit	A IVDR	regulatoryaffairs@eiken.co.jp EUDAMED record Report an error
ElitechGroup FDA	Italy	CPE - Internal Control	A IVDR	Website EUDAMED record Report an error
Eurospital FDA	Italy	Eu-Mag DNA/RNA extraction	A IVDR	regulatory@eurospital.it EUDAMED record Report an error
Geneall EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	AllEx™ Mini Viral DNA/RNA Kit 972-048	A IVDR	Website sales@geneall.com EUDAMED record Report an error
Genetic Signatures FDA EU representative : mdi Europa GmbH (Germany)	Australia	EasyScreen™ Sample Processing Kit3 refs	A IVDR	Website RAQA@geneticsignatures.com EUDAMED record Report an error
Genmark	Türkiye	geneMAP™ Blood RNA Kit	A IVDR	Website info@genmark.com.tr EUDAMED record Report an error
Hangzhou Beiwo Medical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	Pathogen DNA/RNA Purification Kit (Beads) BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96	A IVDR	EUDAMED record Report an error
Hangzhou MiYin Biotechnology EU representative : SUNGO Europe B.V. (Netherlands)	China	TQ-XJ-D-032 ；TQ-XQ-R-0323 refs	A IVDR	EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium)	United States	Aptima Assay Fluids3 refs	A IVDR	EUDAMED record Report an error
Huachenyang (Shenzhen) Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	HCY Nucleic Acid Extraction & Purification Kit CY-M002-50, CY-M002-100, CY-M002-200, CY-M002-96, CY-M001-96, CY-M001-50, CY-M001-100, CY-M001-2003 refs	A IVDR	EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	cfNDA-P1	A IVDR	EUDAMED record Report an error
Immundiagnostik FDA	Germany	MutaCLEAN Virus3 refs	A IVDR	Website info@immundiagnostik.com EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADIPREP3 refs	A IVDR	Website info@khmedical.co.kr EUDAMED record Report an error
Kurabo EU representative : MedNet EC-REP GmbH (Germany)	Japan	QuickGene-AutoS DNA Blood Kit	A IVDR	Website qa@kurabo-grp.com EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	Strongstep® Nucleic acid extraction kit(magnetic beads method) 100 Tests/box98/79	– 98/79	Website sales@limingbio.com EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands)	China	Mag-Bind RNA Extraction Kit 16 Tests, 32 Tests, 48 Tests, 96 Tests (A), 480 Tests (A) ,96 Tests（C）, 480 Tests（C）, 32 Tests（C）	A IVDR	Website EUDAMED record Report an error
Macherey-Nagel FDA	Germany	NucleoMag® Dx Pathogen	A IVDR	Website sales@mn-net.com EUDAMED record Report an error
magtivio	Netherlands	MagSi-DX Pathogen Plus3 refs	A IVDR	info@magtivio.com EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Nucleic Acid Extraction or Purification Reagent NAEPR	A IVDR	EUDAMED record Report an error
Menarinidiagnostics	Italy	PRIME MDx DNA/RNA Extraction kit 2 x48 rxn2 refs	A IVDR	Website EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy)	United States	M-Prep DNA Sample Preparation	A IVDR	Website EUDAMED record Report an error
Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium)	India	MBTREK-01 MBTREK-023 refs	A IVDR	Website ram.kanoje@merillife.com EUDAMED record Report an error
Molzym	Germany	MolYsis-SNplus™ IVD U-300-0122 refs	A IVDR	info@molzym.com EUDAMED record Report an error
Nuclear Laser Medicine	Italy	Estrazione rapida di DNA genomico umano	A IVDR	Website quality@nlm.it EUDAMED record Report an error
PathoNostics	Netherlands	PathoNostics Extraction kit PN-502	A IVDR	Website info@pathonostics.com EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	PaxView DNA Extraction Kit V0101	A IVDR	Website EUDAMED record Report an error
PlexBio FDA EU representative : MDSS GmbH (Germany)	Taiwan	IntelliPrep Blood GenomicDNA Extraction Kit 830153 refs	A IVDR	EUDAMED record Report an error
PreTect FDA	Norway	PreTect X2 refs	A IVDR	Website EUDAMED record Report an error
Qingdao Huaren Medical Product EU representative : Lotus NL B.V. (Netherlands)	China	Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)5 refs98/79	– 98/79	EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®UNITY Universal Extraction Kit	A IVDR	Website EUDAMED record Report an error
RBCBioscience EU representative : Obelis s.a. (Belgium)	Taiwan	MagCore® Circulating DNA large volume kit3 refs	A IVDR	Website EUDAMED record Report an error
Reme-D For Laboratory Equipment Chemicals EU representative : Qualitech International B.V. (Netherlands)	Egypt	COL-NA Universal DE-01-U	A IVDR	Website EUDAMED record Report an error
Rocgene FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	10200602G	A IVDR	sale@rocgene.com EUDAMED record Report an error
Sacace	Italy	DNA-Sorb-A3 refs	A IVDR	Website info@sacace.com EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : PureMDR GmbH (Germany)	China	Nucleic acid extraction and purification kit 96 tests/ kit2 refs	A IVDR	EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RNA033 refs	A IVDR	EUDAMED record Report an error
Shenzhen Huisong Technology Development EU representative : Lotus NL B.V. (Netherlands)	China	Product Name Nucleic Acid Extraction Kit HH-6160	A IVDR	EUDAMED record Report an error
Shenzhen Nucleus Biotechnology EU representative : Kingsmead Service B.V. (Netherlands)	China	Nucleic Acid Extraction Kit NBE01-C	A IVDR	EUDAMED record Report an error
Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands)	China	48 tests	A IVDR	quality.taicang@revvity.com EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Japan	TRCR Purification Kit	A IVDR	csc@tosoh.co.jp EUDAMED record Report an error
Veracyte FDA EU representative : Veracyte Global BV (Netherlands)	France, United States	Veracyte FFPE RNA Extraction Kit	A IVDR	Website EUDAMED record Report an error
Vitapaw Tech Hk EU representative : Maybon Noxa OÜ (Estonia)	Hong Kong SAR China	D3IN1	A IVDR	EUDAMED record Report an error
Vitassay	Spain	Vitassay Microorganism-NA isolation kit	A IVDR	Website info@vitassay.com EUDAMED record Report an error
Vitro FDA	Spain	master diagnóstica MAD-003955M	A IVDR	Website regulatory@vitro.bio EUDAMED record Report an error
Wizbiosolution EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	W73052-100	A IVDR	EUDAMED record Report an error
Zetmedikal	Türkiye	SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit ZT-MAWB98/79	– 98/79	Website info@zetmedikal.com EUDAMED record Report an error
Hangzhou ShengTing Medical Technology EU representative : Medunion S.L. (Spain) No model still on the market	China	Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.198/79 (no longer marketed) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V2.298/79 (no longer marketed) Mycobacterium nucleic acid and M. tuberculosis drug resistance gene detection kit V3.198/79 (no longer marketed) Smartseq-DNA&RNA detection kit V3.198/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Anouve EU representative : Obelis s.a. (Belgium) No model still on the market	China	Anouve 32 tests/box (no longer marketed) Anouve 48 tests/box (no longer marketed) Anouve 50 tests/box (no longer marketed)	A IVDR	Website EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	24 tests/kit98/79 (no longer marketed) 48 tests/kit98/79 (no longer marketed) 96 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）4 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Mobidiag No model still on the market	Finland	Amplidiag Easy Extraction Kit I (no longer marketed)	A IVDR	Website sales.mob@hologic.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 73

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
GENOLUTION. INC. Present in Europe in other categories	South Korea	NX Universal DNA Kit B NUE962 NX-Duo Universal DNA Kit A DUE961 NX Stool NA Kit A CSN231 NX Genomic DNA Kit A NGD041 NX-Duo Genomic DNA Kit A DGD961 NX-Duo cfDNA Kit A DCF242	registered
SARTORIUS STEDIM LAB LIMITED	–	Vivafree 500 Vivafree 2 Vivapore 5 Vivaspin 6 Vivapore 10/20 Vivaspin Turbo 4	registered
ENTOPSIS, LLC	–	PCRopsis	registered
Life Technologies Corporation	United States	Ion Torrent Ion Torrent™ Dx Total NA Isolation Kit (-20 C) Ion Torrent™ Dx cDNA Synthesis Kit This is to test the length of the brand field and what it looks like in the GUDI Ion Torrent™ Dx RNA Quantification Kit Ion Torrent™ Dx DNA Quantification Kit	registered
MERCK MILLIPORE LIMITED Present in Europe in other categories	–	Amicon Ultra – 4 Amicon Ultra – 15 Centriprep-30K Centriprep-10K Minicon B15 Centrifree	registered
Becton, Dickinson & CO Present in Europe in other categories	United States	BD MAX™ ExK™ TNA-2 BD MAX™ ExK™ TNA-3 BD MAX™ ExK™ DNA-1 BD MAX™ ExK™ DNA-2 BD MAX™ ExK™ DNA-3 BD Molecular LBC Sample Buffer Tubes	K182692 (2019)
Biobase Biodustry(Shandong)Co., Ltd.	China	BIOBASE	registered
VIVAPRODUCTS, INC.	United States	Prochem	registered
Hunan Ehome Health Technology Co., Ltd. Present in Europe in other categories	–	Sample Processing kits for Blood Analysis (Canine) Sample Processing kits for Blood Analysis (Feline) Multi-functiona Analyzer for VET Sample Processing kits for Urine/Fecal Analysis	registered
Visby Medical, Inc.	United States	Visby Medical Power Adapter, Right Angle Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack Visby Medical Sexual Health Test Visby Medical Power Adapter	registered
Wallac Oy Present in Europe in other categories	Finland	chemagic DNA CS200 Kit chemagic 360-D Eonis DNA Extraction kit chemagic Prepito -D	registered
Alpha-TEC Systems, Inc.	United States	Alpha-Tec Systems	registered
Scientific Device Laboratory, Inc.	United States	–	registered
APEX BIOLOGIX , LLC	United States	XCELL	registered
HANWOOLTPC Co., Ltd. Present in Europe in other categories	South Korea	Nucleic Acid Extractor	registered
Mawi Dna Technologies, LLC Present in Europe in other categories	–	Mawi DNA Technologies	registered
Quidel Corp.	United States	Solana	K161182 (2016)
Qvella Corporation	–	FAST PBC Prep Cartridge FAST Instrument	registered
Roche Molecular Systems, Inc.	United States	cobas® cfDNA Sample Preparation Kit COBAS® AmpliPrep Instrument	registered
WELLS BIO, INC. Present in Europe in other categories	–	careGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit caerGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit-N	registered
BIOTECHNOLOGY INSTITUTE SL	–	BLOOD SAMPLE CONCENTRATOR KIT	registered
Boditech Med Inc. Present in Europe in other categories	South Korea	NuActor	registered
CHROMA ATE INC. Present in Europe in other categories	Taiwan	CHROMA ATE	registered
Cura Diagnostics Inc.	United States	Xpeedy	registered
Huachenyang (Shenzhen) Technology Co., Ltd	China	iClean	registered
Luminex Molecular Diagnostics, Inc. Present in Europe in other categories	Canada	xTAG® Gastrointestinal Pathogen Panel (GPP)	registered
Streck Laboratories, Inc. Present in Europe in other categories	United States	Streck Viral Extraction Kit	registered
TargetingOne Technology (Beijing) Corporation Present in Europe in other categories	–	TARGETINGONE	registered
WONDFO USA CO., LTD. Present in Europe in other categories	United States	Wondfo	registered
Zhaorui Medical (Shenzhen) Co., LTD	–	Automatic High-throughput Exosome Extractor	registered
Apostle Inc.	United States	–	registered
B.T.I. BIOTECHNOLOGY	Spain	–	registered
BOEN HEALTHCARE CO., LTD. Present in Europe in other categories	China	–	registered
BiOptic Inc.	Taiwan	–	registered
Biomiga, Inc.	United States	–	registered
CalibreScientific US, Inc. Present in Europe in other categories	United States	–	registered
Capitainer AB Present in Europe in other categories	Sweden	–	registered
Changsha Renji Medical Equipment Co., Ltd.	China	–	registered
DYN R&D Ltd.	Israel	–	registered
Diagnostic Automation /Cortez Diagnostics Inc.	United States	–	registered
Diamond Diagnostics Inc. Present in Europe in other categories	United States	–	registered
EntroGen, Inc Present in Europe in other categories	United States	–	registered
Genrui Biotech Inc Present in Europe in other categories	China	–	registered
Guangzhou Four E's Scientific Co., Ltd. Present in Europe in other categories	China	–	registered
Hamilton Bonaduz AG	Switzerland	–	registered
Hamilton Co. Present in Europe in other categories	United States	–	registered
LabTurbo Biotech Corporation	Taiwan	–	registered
Luminex Corporation Present in Europe in other categories	United States	–	registered
Magnet Medical Systems LLC	United States	–	registered
Mark Enterprises	India	–	registered
MilliporeSigma	United States	–	registered
Nanning TECBOD Biological Technology Co.,Ltd	China	–	registered
PLEXUS CORP.	United States	–	registered
Phase Scientific International Limited Present in Europe in other categories	Hong Kong SAR China	–	registered
Q-Line Biotech Limited	India	–	registered
QIAGEN Manchester Ltd	United Kingdom	–	registered
QuidelOrtho Corporation	United States	–	registered
RPI BIOSOLUTIONS	United States	–	registered
Revvity, Inc. Present in Europe in other categories	United States	–	registered
Roche Diagnostics Operations Inc.	United States	–	registered
SARMED SRL	Italy	–	registered
STRATEC SE Present in Europe in other categories	Germany	–	registered
Sanicure BV	Netherlands	–	registered
Sartorius Stedim North America Inc./Sartorius Corporation	United States	–	registered
Shenzhen Dakewe Bio-engineering Co., Ltd Present in Europe in other categories	China	–	registered
Suzhou Sniper Medical Technologies Co., Ltd Present in Europe in other categories	China	–	registered
Svenson Network Holdings Limited	Hong Kong SAR China	–	registered
Tecan U.S., Ltd. Present in Europe in other categories	United States	–	registered
VWR INTERNATIONAL, LLC Present in Europe in other categories	United States	–	registered
Xian Tianlong Science and Technology Co., Ltd. Present in Europe in other categories	China	–	registered
Yantai Addcare Bio-Tech Co., Ltd. Present in Europe in other categories	China	–	registered
Zhejiang GENE SCIENCE Co., Ltd	China	–	registered
Zollner Electronics GmbH	Germany	–	registered

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