| Vitrosens
|
Türkiye
|
154 others
|
B, C
IVDR, 98/79
|
Website
info@vitrosens.com
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| Euroimmun
|
Germany
|
139 others
|
B, C
IVDR, 98/79
|
Website
info@euroimmun.de
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| Gold Standard Diagnostics
|
Germany
|
129 others- Chikungunya Virus IgG capture RE5883198/79
- Chikungunya Virus IgM μ-capture RE5884198/79
- Cytomegalovirus (CMV) IgG ELISA98/79
- Cytomegalovirus (CMV) IgG RE5706198/79
- Cytomegalovirus (CMV) IgM ELISA98/79
- Cytomegalovirus (CMV) IgM RE5707198/79
- Dengue Virus IgG RE5867198/79
- Dengue Virus IgM RE5868198/79
- Dengue Virus IgM µ-capture RE5858198/79
- Epstein-Barr Virus (EA-D) IgG98/79
- Epstein-Barr Virus (EBNA) IgG RE5874198/79
- Epstein-Barr Virus (VCA) IgG RE5875198/79
- Epstein-Barr Virus (VCA) IgM RE5876198/79
- GSD NovaLisa SARS-CoV-2 (COVID-19) quantitative IgG98/79
- GSD NovaPrime® TSP SARS-CoV-22 refs98/79
- Hantavirus IgG98/79
- Hantavirus IgM98/79
- Herpes simplex Virus 1 (HSV 1) IgG98/79
- Herpes simplex Virus 1 (HSV 1) IgG ELISA98/79
- Herpes simplex Virus 1 (HSV 1) IgM98/79
- Herpes simplex Virus 1 (HSV 1) IgM ELISA98/79
- Herpes Simplex Virus 1 IgG ELISA98/79
- Herpes Simplex Virus 1 IgM ELISA98/79
- Herpes simplex Virus 1+2 (HSV) IgG98/79
- Herpes simplex Virus 1+2 (HSV) IgG ELISA98/79
- Herpes simplex Virus 1+2 (HSV) IgM98/79
- Herpes simplex Virus 1+2 (HSV) IgM ELISA98/79
- Herpes Simplex Virus 1+2 IgG ELISA98/79
- Herpes Simplex Virus 1+2 IgM ELISA98/79
- Herpes simplex Virus 2 (HSV 2) IgG98/79
- Herpes simplex Virus 2 (HSV 2) IgG ELISA98/79
- Herpes simplex Virus 2 (HSV 2) IgM98/79
- Herpes simplex Virus 2 (HSV 2) IgM ELISA98/79
- Herpes Simplex Virus 2 IgG ELISA98/79
- Herpes Simplex Virus 2 IgM ELISA98/79
- Influenza Virus A IgA98/79
- Influenza Virus A IgG98/79
- Influenza Virus A IgM98/79
- Influenza Virus B IgA98/79
- Influenza Virus B IgG98/79
- Influenza Virus B IgM98/79
- Measles Virus IgG98/79
- Measles Virus IgG ELISA2 refs98/79
- Measles Virus IgM98/79
- Measles Virus IgM ELISA2 refs98/79
- Mumps Virus IgG98/79
- Mumps Virus IgM98/79
- NovaLisa® Adenovirus IgM2 refs98/79
- NovaLisa® Adenovirus IgA2 refs98/79
- NovaLisa® Adenovirus IgG2 refs98/79
- NovaLisa® Avidity Cytomegalovirus (CMV) IgG98/79
- NovaLisa® Avidity Epstein-Barr Virus (VCA) IgG98/79
- NovaLisa® Avidity Measles Virus IgG98/79
- NovaLisa® Avidity Rubella Virus IgG98/79
- NovaLisa® Chikungunya Virus IgG capture2 refs98/79
- NovaLisa® Chikungunya Virus IgM μ-capture2 refs98/79
- NovaLisa® Cytomegalovirus (CMV) IgG2 refs98/79
- NovaLisa® Cytomegalovirus (CMV) IgM2 refs98/79
- NovaLisa® Dengue Virus IgG2 refs98/79
- NovaLisa® Dengue Virus IgM2 refs98/79
- NovaLisa® Dengue Virus IgM µ-capture2 refs98/79
- NovaLisa® Dengue Virus NS1 Antigen98/79
- NovaLisa® Epstein-Barr Virus (EA-D) IgG98/79
- NovaLisa® Epstein-Barr Virus (EBNA) IgG2 refs98/79
- NovaLisa® Epstein-Barr Virus (VCA) IgG2 refs98/79
- NovaLisa® Epstein-Barr Virus (VCA) IgM2 refs98/79
- NovaLisa® Hantavirus IgG98/79
- NovaLisa® Hantavirus IgM98/79
- NovaLisa® Herpes simplex Virus 1 (HSV 1) IgG2 refs98/79
- NovaLisa® Herpes simplex Virus 1 (HSV 1) IgM2 refs98/79
- NovaLisa® Herpes simplex Virus 1+2 (HSV) IgG2 refs98/79
- NovaLisa® Herpes simplex Virus 1+2 (HSV) IgM2 refs98/79
- NovaLisa® Herpes simplex Virus 2 (HSV 2) IgG2 refs98/79
- NovaLisa® Herpes simplex Virus 2 (HSV 2) IgM2 refs98/79
- NovaLisa® Influenza Virus A IgA2 refs98/79
- NovaLisa® Influenza Virus A IgG2 refs98/79
- NovaLisa® Influenza Virus A IgM2 refs98/79
- NovaLisa® Influenza Virus B IgA2 refs98/79
- NovaLisa® Influenza Virus B IgG2 refs98/79
- NovaLisa® Influenza Virus B IgM2 refs98/79
- NovaLisa® Measles Virus IgG2 refs98/79
- NovaLisa® Measles Virus IgM2 refs98/79
- NovaLisa® Mumps Virus IgG2 refs98/79
- NovaLisa® Mumps Virus IgM2 refs98/79
- NovaLisa® Parainfluenza Virus 1, 2, 3 IgA2 refs98/79
- NovaLisa® Parainfluenza Virus 1, 2, 3 IgG2 refs98/79
- NovaLisa® Parvovirus B19 IgG98/79
- NovaLisa® Parvovirus B19 IgM2 refs98/79
- NovaLisa® Respiratory Syncytial Virus IgA2 refs98/79
- NovaLisa® Respiratory Syncytial Virus IgG2 refs98/79
- NovaLisa® Respiratory Syncytial Virus IgM2 refs98/79
- NovaLisa® Rubella Virus IgG98/79
- NovaLisa® Rubella Virus IgM μ-capture2 refs98/79
- NovaLisa® SARS-CoV-2 (COVID-19) IgA98/79
- NovaLisa® SARS-CoV-2 (COVID-19) IgG98/79
- NovaLisa® TBE / FSME IgM2 refs98/79
- NovaLisa® TBE/FSME IgG2 refs98/79
- NovaLisa® TBE/FSME IgG plus2 refs98/79
- NovaLisa® Varicella-Zoster Virus (VZV) IgG2 refs98/79
- NovaLisa® Varicella-Zoster Virus (VZV) IgM2 refs98/79
- NovaLisa® Zika Virus IgG capture2 refs98/79
- NovaLisa® Zika Virus IgM μ-capture2 refs98/79
- Parainfluenza Virus 1, 2, 3 IgA98/79
- Parainfluenza Virus 1, 2, 3 IgG98/79
- Parvovirus B19 IgG98/79
- Parvovirus B19 IgG ELISA98/79
- Parvovirus B19 IgM98/79
- Parvovirus B19 IgM ELISA98/79
- Respiratory Syncytial Virus IgA98/79
- Respiratory Syncytial Virus IgG98/79
- Respiratory Syncytial Virus IgM98/79
- RSV A, RSV B PRSV616198/79
- RSV A, RSV B PRSV616498/79
- Rubella Virus IgG ELISA98/79
- Rubella Virus IgG RE5708198/79
- Rubella Virus IgM μ-capture ELISA98/79
- Rubella Virus IgM μ-capture RE5709198/79
- SARS-CoV-2 (COVID-19) IgA98/79
- SARS-CoV-2 (COVID-19) IgG98/79
- TBE / FSME IgM98/79
- TBE/FSME IgG98/79
- TBE/FSME IgG plus98/79
- Varicella-Zoster Virus (VZV) IgG ELISA2 refs98/79
- Varicella-Zoster Virus (VZV) IgG RE5737198/79
- Varicella-Zoster Virus (VZV) IgM98/79
- Varicella-Zoster Virus (VZV) IgM ELISA2 refs98/79
- Zika Virus IgG capture ELISA98/79
- Zika Virus IgM μ-capture98/79
- Zika Virus IgM μ-capture ELISA98/79
|
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info.frankfurt@eu.goldstandarddiagnostics.com
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| TestLine Clinical Diagnostics s.r.o
|
Czechia
|
121 others
|
C
IVDR, 98/79
|
Website
info@testlinecd.com
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| Hangzhou Alltest Biotech
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
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81 others
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98/79
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info@alltests.com.cn
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| Sansure
EU representative : Lotus NL B.V. (Netherlands) and 3 others
|
China
|
76 others
|
B, C
IVDR, 98/79
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Website
info@sansure.com.cn
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| Shanghai Zj Bio-Tech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
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China
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64 others
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98/79
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Website
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| Vircell
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Spain
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63 others
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B, C
IVDR, 98/79
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| Acro Biotech
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
United States
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51 others
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info@acrobiotech.com
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| Healgen
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
United States
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51 others
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quality@healgen.com
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| Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇
|
Türkiye
|
49 others- BOCAVIRUS DETECTION KIT VSNR016
- CMV MİKTAR TEST KİTİ
- COVID-19 EASY PREP PCR TANI KİTİ COVID-19 EASY-PREP PCR DIAGNOSTIC KIT
- COVID-19 MULTIPREP FAST
- DENGUE VİRÜSÜ GENOTİPLEME KİTİ
- DENGUE VİRÜSÜ TESPİT KİTİ
- EBV Quantification Kit
- ENTEROVIRUS DETECTION KIT VSNMP054
- H1N1 TESPİT KİTİ H1N1 DETECTION KIT
- HHV-6 Quantification Kit
- HHV-8 DETECTION KIT
- HHV6-HHV7 DETECTION KIT
- HPV (16-18) HIGH RISK DETECTION KIT
- HPV (16-18-31) HIGH RISK DETECTION KIT
- HPV 6/11 Tespit Kiti HPV 6/11 DETECTION KIT
- HPV DÜŞÜK RİSKLİ GENOTİPLEME GERÇEK ZAMANLI PCR KİTİ
- HPV YÜKSEK RİSK VE 6-11 GERÇEK ZAMANLI PCR KİTİ HPV HIGH RISK AND 6-11 REAL-TIME PCR KIT
- HSV-1 Detection Test Kit
- HSV-2 DetectionTest Kit
- HUMAN METAPNEUMOVIRUS DETECTION KIT VSNR001
- HUMAN PARECHOVIRUS DETECTION KIT VSNR019
- INF A/H1 TESPİT KİTİ INF A/H1 DETECTION KIT
- INF A/H1-2009 TESPİT KİTİ INF A/H1-2009 DETECTION KIT
- INF A/H3 TESPİT KİTİ INF A/H3 DETECTION KIT
- İNFLUENZA A-H5N1 TESPİT KİTİ INFLUENZA A- H5N1 DETECTION KIT
- İNFLUENZA -A,B TESPİT KİTİ
- İNFLUENZA -B TESPİT KİTİ
- İNFLUENZA A-B-C TARAMA KİTİ
- İNFLUENZA H5N2 TESPİT KİTİ INFLUENZA H5N2 DETECTION KIT
- İNFLUENZA TİPLEME KİTİ
- İNFLUENZA-A TESPİT KİTİ
- JCV Quantification Kit
- MINI SMEAR SET
- MINI SMEAR SET V2 MINI SMEAR SETİ V2
- PARAİNFLUENZA (1, 2, 3, 4) TESPİT KİTİ PARAINFLUENZA (1, 2, 3, 4) DETECTION KIT
- Parvovirus B19 Quantification Kit
- RHINOVIRUS (A,B,C) DETECTION KIT VSNR017
- RUBELLA DETECTION KIT VSNRD007
- SAMPLE CONTAINER VSNS009
- SARS-COV-2 MUTATION DETECTION KİT
- SMEAR SAMPLING KIT
- SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) -A,B TESPİT KİTİ
- SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – B TESPİT KİTİ
- SOLUNUM SİNSİTİYAL VİRÜSÜ (RSV) – TEST KİTİ
- VISION COVID-19 EASYPREP-FAST PCR DIAGNOSTIC KIT
- VZV (HHV-3) MİKTARLANDIRMA KİTİ VZV (HHV-3) QUANTIFICATION KIT
- West Nile Virus Quantification Kit
- ZIKA VİRÜSÜ TESPİT KİTİ
- ÇİKUNGUNYA VİRÜSÜ TESPİT KİTİ
|
A, B, C
IVDR
|
Website
info@visionbiotechnology.com
EUDAMED record
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| Orientgene
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
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43 others
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98/79
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EUDAMED record
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| Vidia
|
Czechia
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42 others
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98/79
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Website
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| Wuhan Easydiagnosis Biomedicine
EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others
|
China
|
95 others- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + anterior nasal swab (short version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab + throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Positive and negative controls)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Positive control)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:A-1,1 Test/kit (Nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short version)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit ()Nasal swab + anterior nasal swab (short versionNasal swab + anterior nasal swab (long version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Anterior nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Positive control)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit ( Positive and negative controls)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Anterior nasal swab (short version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Anterior nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (long version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab + throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit (Positive control)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-10,10 Tests/kit(Throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Anterior nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (long version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Positive and negative controls)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Positive control)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit(Anterior nasal swab (short version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Anterior nasal swab (short version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Anterior nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab + throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Nasal swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Positive and negative controls)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Positive control)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit (Throat swab)98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-5,5 Tests/kit(Nasal swab + anterior nasal swab (long version))98/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-B0198/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag05-C0198/79
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-B0198/79
- Adenovirus(Adeno) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed)
- AP1:24 tests/kit98/79 (no longer marketed)
- AP1:48 tests/kit98/79 (no longer marketed)
- AP1:96 tests/kit98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-1,1 Test/kit (Nasal swab + throat swab)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:B-20,20 Tests/kit (Nasal swab + anterior nasal swab (short version))98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit (Positive control)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-10, 10Tests/kit(Positive and negative controls)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab (short version))98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Anterior nasal swab)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + anterior nasal swab (long version))98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab + throat swab)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Nasal swab)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Positive control)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit (Throat swab)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-20, 20Tests/kit(Nasal swab + anterior nasal swab (short version))98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit Type:C-5, 5Tests/kit (Nasal swab + throat swab)98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag01-C1098/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag02-C10,98/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag03-C1098/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag04-C1098/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag05-C1098/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag06-C1098/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag07-C1098/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag08-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0198/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C0598/79 (no longer marketed)
- COVID-19 (SARS-CoV-2) Antigen Test Kit W-Ag09-C2098/79 (no longer marketed)
- HPV (16+18)Rapid Test 20 tests/kit98/79 (no longer marketed)
- HPV (16+18)Rapid Test 40 tests/kit98/79 (no longer marketed)
- Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed)
- Influenza A+B/RSV Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)
- Norovirus(NORO) Test Kit (Immunofluorescence Method) 20 tests/kit2 refs98/79 (no longer marketed)
- QP1:100 tests/kit2 refs98/79 (no longer marketed)
- QP1:25 tests/kit98/79 (no longer marketed)
- QP1:50 tests/kit98/79 (no longer marketed)
- Respiratory Syncytial Virus Antigen(RSV Ag) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed)
- Respiratory Syncytial Virus Antigen(RSV Ag) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)
- Rota/Adeno Combo Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed)
- Rota/Adeno Combo Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)
- Rotavirus (ROTA) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed)
|
–
98/79
|
EUDAMED record
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| Abbott
EU representative : Abbott GmbH (Germany) and 1 other
|
Germany, Ireland, South Korea, United States
|
43 others
|
B, C
IVDR, 98/79
|
Website
EUDAMED record
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|
| Idilbiotech
|
Türkiye
|
41 others
|
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98/79
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Website
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| Neomedica
EU representative : Wellkang Ltd (Northern Ireland)
|
Serbia
|
38 others
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98/79
|
Website
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| Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi
|
Türkiye
|
37 others
|
C
IVDR, 98/79
|
Website
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| Beijing Applied Biological Technologies
EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other
|
China
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35 others
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98/79
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Report an error
|
| altona Diagnostics
|
Germany
|
34 others
|
B, C
IVDR, 98/79
|
info@altona-diagnostics.com
EUDAMED record
Report an error
|
| Vela Operations Singapore Pte
EU representative : Vela Diagnostics Germany GmbH (Germany)
|
Singapore
|
31 others
|
–
98/79
|
Website
infoAPAC@veladx.com
EUDAMED record
Report an error
|
| Clonit
|
Italy
|
30 others
|
C
IVDR, 98/79
|
Website
info@clonit.it
EUDAMED record
Report an error
|
| DiaSorin
EU representative : DiaSorin Italia S.p.A. (Italy)
|
Italy, United States
|
30 others
|
B, C
IVDR, 98/79
|
Website
ivdr_dsm@diasorin.com
EUDAMED record
Report an error
|
| TIB MOLBIOL Syntheselabor
|
Germany
|
25 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Lifotronic
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
23 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Diesse
|
Italy
|
22 others
|
B, C
IVDR
|
Website
EUDAMED record
Report an error
|
| Encode
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
22 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| bioMérieux
|
France
|
21 others
|
B, C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Geneproof
|
Czechia
|
21 others
|
C
IVDR, 98/79
|
Website
support@geneproof.com
EUDAMED record
Report an error
|
| Rapid Labs
EU representative : Advena Limited (Malta) and 1 other
|
United Kingdom (ex Northern Ireland)
|
18 others
|
–
98/79
|
Website
info@rapidlabs.co.uk
EUDAMED record
Report an error
|
| Suzhou TianLong Biotechnology
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
17 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Hangzhou Laihe Biotech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
16 others
|
–
98/79
|
office@lyher.com
EUDAMED record
Report an error
|
| Kangsheng Information Technology (Hangzhou)
EU representative : Crealkraft GmbH (Germany)
|
China
|
16 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Poly Diagnostics
|
Luxembourg
|
- Poly Diagnostics Adenovirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Astrovirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Bocavirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Coronaviruses 229E, OC43, NL63, HKU1, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Coronaviruses 229E/HKU1, OC43, NL63, RNase P Real-Time PCR kit3 refs
16 others- Poly Diagnostics HMPV A/B, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics HRSV a/b, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Influenza A, Influenza B, Influenza C, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Influenza A, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Influenza B, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Influenza typing II Real-Time PCR kit3 refs
- Poly Diagnostics Influenza typing Real-Time PCR kit3 refs
- Poly Diagnostics Mumps virus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Norovirus GI, Norovirus GII+GIV, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Parainfluenza viruses 1, 2, 3, 4 Real-Time PCR kit3 refs
- Poly Diagnostics Parainfluenza viruses 1, 2, 3/4, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Parechovirus, HMPV A/B, Bocavirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Parechovirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Rhinovirus/Enterovirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Rotavirus A, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics SARS-CoV-2, RNase P Real-Time PCR kit3 refs
|
B
IVDR
|
Website
info@polydiagnostics.com
EUDAMED record
Report an error
|
| Ab Analitica
|
Italy
|
15 others
|
–
98/79
|
customersupport@abanalitica.it
EUDAMED record
Report an error
|
| Bioperfectus
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
15 others
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Hightopbio
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
15 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Mikrogen
|
Germany
|
15 others
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Technogenetics
|
Italy
|
15 others
|
B, C
IVDR
|
Website
QA@TECHNOGENETICS.IT
EUDAMED record
Report an error
|
| Vitassay
|
Spain
|
15 others
|
–
98/79
|
Website
info@vitassay.com
EUDAMED record
Report an error
|
| BeijingModern GaoDa Biotechnology
EU representative : Medunion S.L. (Spain)
|
China
|
14 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Boditech
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
14 others
|
B
IVDR, 98/79
|
Website
marketing@boditech.co.kr
EUDAMED record
Report an error
|
| Hybribio
EU representative : Emergo Europe B.V. (Netherlands) and 2 others
|
China
|
13 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Jiangsu Mole Bioscience
EU representative : Lotus NL B.V. (Netherlands) and 2 others
|
China
|
13 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Trinitybiotech
EU representative : TrinityBiotech (Ireland)
|
United States
|
13 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| R-Biopharm
|
Germany
|
13 others
|
B
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Cowingene
EU representative : MedPath GmbH (Germany)
|
China
|
12 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Orgentec
|
Germany
|
12 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Certest
|
Spain
|
11 others
|
B, C
IVDR
|
Website
quality@certest.es
EUDAMED record
Report an error
|
| ELITechGroup
|
Italy
|
11 others
|
B, C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Hangzhou Immuno Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
11 others
|
–
98/79
|
info@jgbiotech.com
EUDAMED record
Report an error
|
| Wondfo
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
11 others
|
–
98/79
|
Website
sales@wondfo.com.cn
EUDAMED record
Report an error
|
| Arcdia
|
Finland
|
10 others
|
–
98/79
|
Website
office@arcdia.com
EUDAMED record
Report an error
|
| Ecolidx
|
Czechia
|
10 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Advanced Molecular Diagnostics
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
9 others
|
–
98/79
|
Website
info@am-diagnostics.co.uk
EUDAMED record
Report an error
|
| Aesku
|
Germany
|
9 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic
|
Türkiye
|
9 others
|
C
IVDR, 98/79
|
Website
info@anatoliagenetik.com
EUDAMED record
Report an error
|
| Autobio Diagnostics
EU representative : QbD RepS BV (Belgium)
|
China
|
9 others
|
C
IVDR, 98/79
|
info@autobio-diagnostics.com
EUDAMED record
Report an error
|
| Cybereagen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
9 others
|
–
98/79
|
info@cybereagen.com
EUDAMED record
Report an error
|
| Immundiagnostik
|
Germany
|
9 others
|
–
98/79
|
Website
info@immundiagnostik.com
EUDAMED record
Report an error
|
| Monobind
EU representative : AR Experts B.V. (Netherlands)
|
United States
|
9 others
|
–
98/79
|
Website
info@monobind.com
EUDAMED record
Report an error
|
| Ortho-Clinical Diagnostics Dba Quidel
EU representative : MDSS GmbH (Germany)
|
United States
|
9 others
|
–
98/79
|
Website
PRRC@quidelortho.com
EUDAMED record
Report an error
|
| Bioer
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
8 others
|
B, C
IVDR, 98/79
|
Website
ra_oversea@bioer.com.cn
EUDAMED record
Report an error
|
| Genes2Me
EU representative : Obelis s.a. (Belgium)
|
India
|
8 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| HEALSTONE Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
Canada
|
8 others
|
–
98/79
|
sales@orientgene.com
EUDAMED record
Report an error
|
| Shenzhen Yhlo Biotech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
8 others
|
C
IVDR
|
Website
info@szyhlo.com
EUDAMED record
Report an error
|
| Shenzhen Zijian Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
- 15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing) 48 Tests/kit98/79
- Adenovirus FIA Kit 25 Tests/kit98/79
- Adenovirus IgM Detection Kit(CLIA) 50 Tests/kit98/79
- Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79
- Enterovirus type 71 (EV71) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79
8 others
|
–
98/79
|
Website
sales@szzijian.com
EUDAMED record
Report an error
|
| Assure Tech. (Hangzhou)
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
7 others
|
B
IVDR, 98/79
|
Website
contact@diareagent.com
EUDAMED record
Report an error
|
| HangZhou Biotest Biotech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
|
China
|
7 others
|
–
98/79
|
info@biotests.com.cn
EUDAMED record
Report an error
|
| Molbio Diagnostics
EU representative : QbD RepS BV (Belgium)
|
India
|
7 others
|
–
98/79
|
Website
customersupport@molbiodiagnostics.com
EUDAMED record
Report an error
|
| Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş
|
Türkiye
|
7 others
|
–
98/79
|
Website
info@turklab.com.tr
EUDAMED record
Report an error
|
| Viramed
|
Germany
|
7 others
|
B, C
IVDR
|
Website
EUDAMED record
Report an error
|
| Beijing Jinwofu Bioengineering Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
6 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Getein
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
6 others
|
B, C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Jiangsu Macro & Micro-Test Med-Tech
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
6 others
|
B
IVDR, 98/79
|
marketing@hongweitest.com
EUDAMED record
Report an error
|
| Bioeksen
|
Türkiye
|
5 others
|
–
98/79
|
Website
info@bioeksen.com.tr
EUDAMED record
Report an error
|
| Realytech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
5 others
|
–
98/79
|
Website
info@realytech.com
EUDAMED record
Report an error
|
| Shanghai BioGerm Medical Technology
EU representative : MedNet EC-REP GmbH (Germany) and 2 others
|
China
|
5 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Siemens Healthcare Diagnostics
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
|
United States
|
5 others
|
C
IVDR, 98/79
|
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
|
| Daan Gene
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
4 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Hangzhou Danwei Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
4 others
|
–
98/79
|
ra.danwei@danwei-bio.com
EUDAMED record
Report an error
|
| Kogene
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
4 others
|
–
98/79
|
Website
info@kogene.co.kr
EUDAMED record
Report an error
|
| Anhui Deepblue Medical Technology
EU representative : Medunion S.L. (Spain)
|
China
|
3 others
|
–
98/79
|
sales@dbluemedical.com
EUDAMED record
Report an error
|
| Dezhou Guoke Medical Technology
EU representative : MedPath GmbH (Germany) and 1 other
|
China
|
3 others- Dengue IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79
- Zika Virus IgG/IgM Antibody Rapid Test Kit GKPD12098/79
|
–
98/79
|
office@guoke-medical.com
EUDAMED record
Report an error
|
| Diagreat
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
3 others
|
B, C
IVDR
|
Website
info@diagreat.com
EUDAMED record
Report an error
|
| Diapro
|
Italy
|
3 others
|
–
98/79
|
Website
info@diapro.it
EUDAMED record
Report an error
|
| gerbion
|
Germany
|
3 others
|
–
98/79
|
info@gerbion.com
EUDAMED record
Report an error
|
| Medotexbio
EU representative : HUMISS TRADING S. L. (Spain) and 1 other
|
China
|
3 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Mindray
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
3 others
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Oxoid
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
3 others
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Seramun
|
Germany
|
3 others
|
–
98/79
|
info@seramun.com
EUDAMED record
Report an error
|
| Siemens Healthcare Diagnostics Products
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
|
United Kingdom (ex Northern Ireland)
|
3 others
|
B, C
IVDR
|
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
|
| Singuway
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
3 others
|
–
98/79
|
sales@singuway.com
EUDAMED record
Report an error
|
| Human
|
Germany
|
3 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Ablsa
|
Luxembourg
|
2 others
|
–
98/79
|
Website
contact@ablsa.com
EUDAMED record
Report an error
|
| Aitbiotech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
Singapore
|
2 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Anchor Diagnostics
|
Germany
|
2 others
|
C
IVDR, 98/79
|
info@anchor-diagnostics.com
EUDAMED record
Report an error
|
| Hologic
EU representative : Hologic BV (Belgium)
|
United States
|
2 others
|
B, C
IVDR
|
EUDAMED record
Report an error
|
| Inbios
EU representative : AR Experts B.V. (Netherlands)
|
United States
|
2 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Ingenetix
|
Austria
|
2 others
|
–
98/79
|
Website
office@ingenetix.com
EUDAMED record
Report an error
|
| Keyubio
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
2 others
|
–
98/79
|
Website
export@keyubio.com
EUDAMED record
Report an error
|
| Seegene
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
2 others
|
C
IVDR, 98/79
|
Website
info@seegene.com
EUDAMED record
Report an error
|
| Tellgencorp
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
2 others
|
–
98/79
|
Website
sales@tellgen.com
EUDAMED record
Report an error
|
| Ustar Biotechnologies (Hangzhou)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
2 others
|
B, C
IVDR, 98/79
|
Website
service@bioustar.com
EUDAMED record
Report an error
|
| Zhejiang Greylynx Biotech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
2 others
|
–
98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Tosoh
EU representative : Tosoh Europe N.V. (Belgium)
|
Japan
|
5 others
|
C
IVDR, 98/79
|
csc@tosoh.co.jp
EUDAMED record
Report an error
|
| Qiagen
|
Germany
|
2 others
|
–
98/79
|
Website
info@qiagen.com
EUDAMED record
Report an error
|
| Agilent
EU representative : Agilent Technologies Denmark ApS (Denmark)
|
Singapore, United States
|
1 other
|
C
IVDR, 98/79
|
Website
info.dk@agilent.com
EUDAMED record
Report an error
|
| DiagCor Life Science
EU representative : Medunion S.L. (Spain) and 1 other
|
Hong Kong SAR China
|
1 other
|
–
98/79
|
QARA@diagcorlifescience.com
EUDAMED record
Report an error
|
| Eurobio Scientific
|
France
|
1 other
|
–
98/79
|
reglementaire@eurobio-scientific.com
EUDAMED record
Report an error
|
| Genekam
|
Germany
|
1 other
|
–
98/79
|
Website
office@genekam.de
EUDAMED record
Report an error
|
| Iontek
|
Türkiye
|
1 other
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Isiabio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
1 other
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| KH Medical
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
1 other
|
–
98/79
|
Website
info@khmedical.co.kr
EUDAMED record
Report an error
|
| NanoEntek
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
1 other
|
–
98/79
|
Website
eudamed@nanoentek.com
EUDAMED record
Report an error
|
| Phasescientific
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
Hong Kong SAR China
|
1 other
|
–
98/79
|
Website
info@phasesci.com
EUDAMED record
Report an error
|
| Progenie molecular S.L.U
|
Spain
|
1 other
|
–
98/79
|
EUDAMED record
Report an error
|
| Shenzhen New Industries Biomedical Engineering
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
1 other
|
B
IVDR
|
Website
EUDAMED record
Report an error
|
| Singclean
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
1 other
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Vivachek
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
1 other
|
–
98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Wuhan Life Origin Biotech Joint Stock
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
1 other
|
–
98/79
|
EUDAMED record
Report an error
|
| Xiamen Zeesan Biotech
EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other
|
China
|
1 other
|
–
98/79
|
info@zsandx.com
EUDAMED record
Report an error
|
| Zhejiang QL Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
1 other
|
–
98/79
|
EUDAMED record
Report an error
|
| Daltonbio
EU representative : MedPath GmbH (Germany) and 1 other
|
China
|
1 other
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Anhui Formaster Biosci
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Dynamiker
EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other
|
China
|
|
–
98/79
|
Website
marketing@dynamiker.com
EUDAMED record
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|
| Hecin
EU representative : Share info GmbH (Germany)
|
China
|
|
B
IVDR
|
EUDAMED record
Report an error
|
| Maccura
EU representative : Humiss International B.V. (Netherlands) and 1 other
|
China
|
|
–
98/79
|
Website
EUDAMED record
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|
| Microprofit
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Nanjing Synthgene Medical Technology
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
|
–
98/79
|
Website
sales@syngenebio.com
EUDAMED record
Report an error
|
| Ningbo BESTest Bio-technology
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
B, C
IVDR, 98/79
|
EUDAMED record
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|
| Targetingone
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Yanengbio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| ZeptoMetrix
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
B
IVDR
|
Website
EUDAMED record
Report an error
|
| Anbio
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
|
–
98/79
|
info@anbio.com
EUDAMED record
Report an error
|
| Beckman Coulter
EU representative : Beckman Coulter Ireland Inc. (Ireland)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
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|
| Bgi
|
Denmark
|
|
–
98/79
|
Website
EUDAMED record
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|
| Capitalbiotech
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Cesna
|
Türkiye
|
|
B
IVDR
|
Website
info@cesna.com.tr
EUDAMED record
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|
| Credo Diagnostics Biomedical Pte Taiwan Branch
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
|
–
98/79
|
service@credodxbiomed.com
EUDAMED record
Report an error
|
| Genesignbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
|
China
|
|
–
98/79
|
info@genesignbio.com
EUDAMED record
Report an error
|
| Gensurebio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
Website
info@gensurebio.com
EUDAMED record
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|
| Jiangsu Q-Array
EU representative : Caretechion GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Kangmei Tianhong Biotech (Beijing)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
info@kindmay.com
EUDAMED record
Report an error
|
| Kingcreate
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
|
China
|
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| PaxGenBio
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Rayto
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
Website
support@rayto.com
EUDAMED record
Report an error
|
| Reagena
|
Finland
|
|
–
98/79
|
Website
info@reagena.com
EUDAMED record
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|
| Shenzhen YOUYI Bioscience
EU representative : Medunion S.L. (Spain) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Synthgene (Yixing) Health Technology
EU representative : MedPath GmbH (Germany)
|
China
|
|
–
98/79
|
sales@syngenebio.com
EUDAMED record
Report an error
|
| Thermofisher
EU representative : Life Technologies Europe B.V. (Netherlands)
|
United States
|
|
–
98/79
|
EUDAMED record
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|
| Vazyme
EU representative : Obelis s.a. (Belgium) and 2 others
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| 3D Biomedicine Science & Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Abiores Technology (Beijing)
EU representative : Medunion S.L. (Spain) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Şi̇rketi̇
|
Türkiye
|
|
A
IVDR
|
Website
info@antmedical.com
EUDAMED record
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|
| Atlas Medical
|
Germany
|
|
–
98/79
|
Website
info@atlas-medical.com
EUDAMED record
Report an error
|
| Cepheid
EU representative : Cepheid AB (Sweden)
|
Sweden, United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Coyotebio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
sales@coyotebio.com
EUDAMED record
Report an error
|
| Fanttest
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
info@fanttest.com
EUDAMED record
Report an error
|
| GenDx
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China, United States
|
|
–
98/79
|
Website
orders@genbio.com
EUDAMED record
Report an error
|
| GeneFirst
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Guangzhou Biotron Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Hangzhou Zhunxin Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti
|
Türkiye
|
|
–
98/79
|
Website
info@koroglugroup.com
EUDAMED record
Report an error
|
| Microbiologics
EU representative : MediMark Europe Sarl. (France)
|
United States
|
|
B
IVDR
|
Website
info@microbiologics.com
EUDAMED record
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|
| Norgen Biotek
EU representative : Emergo Europe B.V. (Netherlands)
|
Canada
|
|
B
IVDR
|
Website
regulatory@norgenbiotek.com
EUDAMED record
Report an error
|
| Ortho-Clinical Diagnostics Summers Ridge San Diego
EU representative : MDSS GmbH (Germany)
|
United States
|
|
–
98/79
|
Website
PRRC@quidelortho.com
EUDAMED record
Report an error
|
| Shenzhen Huian Biosci Technology
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
–
98/79
|
info@huiantech.com
EUDAMED record
Report an error
|
| Toda Pharma
|
France
|
|
–
98/79
|
Website
qualite@todapharma.com
EUDAMED record
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|
| Vellap
|
Germany
|
|
–
98/79
|
info@vellap.de
EUDAMED record
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|
| Viuick
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Wizbiotech
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| PathoFinder
|
Netherlands
|
|
B
IVDR, 98/79
|
Website
info@pathofinder.com
EUDAMED record
Report an error
|
| AccuBioTech
EU representative : MDSS GmbH (Germany)
|
China
|
|
–
98/79
|
sales@accubiotech.com
EUDAMED record
Report an error
|
| Aconbio
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| AD Nucleis
|
France
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Aichek
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
ra.rep@aichek.com
EUDAMED record
Report an error
|
| AusDiagnostics
EU representative : Advena Limited (Malta)
|
Australia
|
|
–
98/79
|
Website
regulatory@r-biopharm.com.au
EUDAMED record
Report an error
|
| Becton Dickinson
EU representative : Becton Dickinson Ireland Limited (Ireland)
|
United States
|
|
B, C
IVDR
|
Website
EUDAMED record
Report an error
|
| Bio-Novum
|
Poland
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Biocare Medical
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Biosynex
|
France
|
|
–
98/79
|
Website
reglementaire@biosynex.com
EUDAMED record
Report an error
|
| Bosonbio
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Campmedica
|
Romania
|
|
B
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Clongene
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
Website
marketing@clongene.com
EUDAMED record
Report an error
|
| Diagenode
|
Belgium
|
|
C
IVDR
|
info@diagenode.com
EUDAMED record
Report an error
|
| Dirui
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
|
Germany
|
|
–
98/79
|
Website
info@gfeblut.de
EUDAMED record
Report an error
|
| Guangzhou Deaou Gene Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Hain Lifescience
|
Germany
|
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Hunan Kangxin Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Hysenbiotech
EU representative : Medunion S.L. (Spain)
|
South Korea
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Igenesis Shanghai
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
support@igenesisbio.com
EUDAMED record
Report an error
|
| InTec PRODUCTS
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
|
Türkiye
|
|
–
98/79
|
info@kinetikkimya.com
EUDAMED record
Report an error
|
| Lysunbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Meridian Bioscience
EU representative : Meridian Bioscience Europe S.r.l. (Italy)
|
United States
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Mpbio
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Ningbo HEALTH Gene Technologies
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Operon
|
Spain
|
|
–
98/79
|
Website
infoeudamed@operon.es
EUDAMED record
Report an error
|
| Pluslife
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
|
China
|
|
–
98/79
|
Website
ra@pluslife.com
EUDAMED record
Report an error
|
| Precision Biosensor
EU representative : mdi Europa GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
info@precision-bio.com
EUDAMED record
Report an error
|
| Rastin
EU representative : Source of Commerce GmbH (Germany)
|
Iran
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Remel
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Rocgene
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
sale@rocgene.com
EUDAMED record
Report an error
|
| RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi
|
Türkiye
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| SD Biosensor
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Sejoy
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Self-screen
|
Netherlands
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Shanghai Rendu Biotechnology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
C
IVDR
|
EUDAMED record
Report an error
|
| Shenzhen Chenghui Medical Technology
EU representative : HUMISS TRADING S. L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Triplex International Biosciences (China)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
info@tibchina.com
EUDAMED record
Report an error
|
| Vitro
|
Spain
|
|
C
IVDR
|
Website
regulatory@vitro.bio
EUDAMED record
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|
| Zhongshan Bio-Tech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| 1drop
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
sales@1drop.co.kr
EUDAMED record
Report an error
|
| 3Bblackbio
EU representative : Wellkang Ltd (Northern Ireland)
|
India
|
|
C
IVDR
|
Website
info@3bblackbio.com
EUDAMED record
Report an error
|
| Abacus Diagnostica
|
Finland
|
|
–
98/79
|
info@abacusdiagnostica.com
EUDAMED record
Report an error
|
| Abviris
|
Germany
|
|
–
98/79
|
Website
info@abviris.de
EUDAMED record
Report an error
|
| Acesolab
EU representative : VidaQuick Biotech S.L. (Spain)
|
United States
|
|
–
98/79
|
info@acesolab.com
EUDAMED record
Report an error
|
| Actest
EU representative : VidaQuick Biotech S.L. (Spain)
|
China
|
|
–
98/79
|
info@actest.com.cn
EUDAMED record
Report an error
|
| Appolon Bioteck
|
France
|
|
–
98/79
|
Website
contact@appolonbioteck.com
EUDAMED record
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|
| Arghavan Teb Kavian
EU representative : Medisol Technologies S.L. (Spain)
|
Iran
|
|
C
IVDR
|
Website
info@atkdiagnostic.com
EUDAMED record
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|
| AVE Science & Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Beijing Lepu Medical Technology
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Beijing Microfuture Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Beijing Wantai Biological Pharmacy Enterprise
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Beijing Zhongjian Antai Diagnostic Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
B
IVDR
|
EUDAMED record
Report an error
|
| Bio-Rad
|
France
|
|
C
IVDR
|
Website
contact@bio-rad.com
EUDAMED record
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|
| Bio-Rad Laboratories
EU representative : Bio-Rad (France)
|
United States
|
|
C
IVDR
|
Website
contact@bio-rad.com
EUDAMED record
Report an error
|
| Biobase Diagnostic Technology (Shandong)
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| BioChain (Beijing) Science & Technology
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| BioFynder
EU representative : SUNGO Europe B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Biopanda
|
Northern Ireland
|
|
–
98/79
|
Website
info@biopanda.co.uk
EUDAMED record
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|
| Chengdu One-Chip Biotechnology
EU representative : Share info GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| CTK Biotech
EU representative : MDSS GmbH (Germany)
|
United States
|
|
C
IVDR
|
Website
info@ctkbiotech.com
EUDAMED record
Report an error
|
| Demeditec
|
Germany
|
|
–
98/79
|
Website
info@demeditec.de
EUDAMED record
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|
| Dialab
|
Austria
|
|
–
98/79
|
Website
office@dialab.at
EUDAMED record
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|
| Dianabiotech
|
Czechia
|
|
–
98/79
|
Website
info@dianabiotech.com
EUDAMED record
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|
| Diatech Pharmacogenetics
|
Italy
|
|
C
IVDR
|
Website
info@diatechpharmacogenetics.com
EUDAMED record
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|
| Dutch Diagnostics
|
Netherlands
|
|
–
98/79
|
Website
info@dutch-diagnostics.com
EUDAMED record
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|
| Edna
|
Türkiye
|
|
–
98/79
|
Website
EUDAMED record
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|
| Elisabeth
|
Czechia
|
|
–
98/79
|
Website
info@elisabeth.cz
EUDAMED record
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|
| FRIZ Biochem
|
Germany
|
|
B
IVDR
|
Website
info@frizbiochem.de
EUDAMED record
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|
| Fujirebio
|
Belgium
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Genmark
|
Türkiye
|
|
–
98/79
|
Website
info@genmark.com.tr
EUDAMED record
Report an error
|
| Genobio Pharmaceutical
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
Website
marketing@era-bio.com
EUDAMED record
Report an error
|
| Gold Probe Diagnostic Biotechnology Mf
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Hangzhou DIAN Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Hangzhou New Horizon Health Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
Website
compliance@nhbio.com.cn
EUDAMED record
Report an error
|
| Hangzhou Testsea Biotechnology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| IBL International
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Id Solutions
|
France
|
|
–
98/79
|
Website
info@id-solutions.fr
EUDAMED record
Report an error
|
| LGC Clinical Diagnostics
EU representative : MediMark Europe Sarl. (France)
|
United States
|
|
B
IVDR
|
EUDAMED record
Report an error
|
| Limingbio
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
–
98/79
|
Website
sales@limingbio.com
EUDAMED record
Report an error
|
| MedicalSystem Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Monlab
|
Spain
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Newlink Biotech
EU representative : VidaQuick Biotech S.L. (Spain)
|
China
|
|
–
98/79
|
Website
info@kylinew.com
EUDAMED record
Report an error
|
| Pharmaline
|
Türkiye
|
|
C
IVDR
|
info@pharmaline.com.tr
EUDAMED record
Report an error
|
| Remel Europe
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Sentinel
|
Italy
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Shenzhen Superbio Technology
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
info@sup-bio.com
EUDAMED record
Report an error
|
| Todylaboratories
|
Romania
|
|
A
IVDR
|
Website
contact@todylaboratories.com
EUDAMED record
Report an error
|
| Ukinbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
sales@ukinbio.com
EUDAMED record
Report an error
|
| Vacure
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Wwhsbio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
info@wwhsbio.com
EUDAMED record
Report an error
|
| Zhejiang Anji Saianfu Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
No model still on the market
|
China
|
5 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Princeton BioMeditech
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
No model still on the market
|
United States
|
2 others
|
–
98/79
|
Website
info@pbmc.com
EUDAMED record
Report an error
|
| Biotime
EU representative : Medunion S.L. (Spain)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Nantong EgensBiotechnology
EU representative : SUNGO Europe B.V. (Netherlands)
No model still on the market
|
China
|
|
–
98/79
|
qa@egens-bio.cn
EUDAMED record
Report an error
|
| Diasia
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Uniogen
No model still on the market
|
Finland
|
|
–
98/79
|
info@uniogen.com
EUDAMED record
Report an error
|