IVD generic use consumables

IVD general use consumable devices - other

EMDN code W0599

117 manufacturers, 440 models including 435 on the market, 19 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 117

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
Nanjing Superfit I & E EU representative : SUNGO Europe B.V. (Netherlands)	China	Superfirt 0.2ml, 0.5ml, 1.5ml, 2ml, 5ml, 7ml, 10ml, 15ml, 50ml, 100ml3 refs Superfirt 0.2ml（48wells, 60wells, 72wells, 96wells）/0.5ml(48wells, 60wells, 72wells, 96wells)/1.5ml(48wells, 60wells, 72wells, 96wells) /5ml(24wells, 32wells, 48wells, 60wells) and 15ml, 50ml3 refs Superfirt 0.5ml/1ml/1.5ml/1.8ml/2ml/5ml/10ml3 refs Superfirt 0.5ml/1ml/2ml/3ml/5ml/10ml3 refs Superfirt 10ml,100ml,250ml,500ml,1000ml,2000ml3 refs 16 others Superfirt 10ml,20ml,50ml,100ml,250ml,500ml,1000ml3 refs Superfirt 10ul, 20ul, 50ul, 100ul, 200ul, 300ul, 1000ul, 5000ul, 10ml3 refs Superfirt 125ml,250ml,500ml3 refs Superfirt 12mm/13mm/16mm/20mm3 refs Superfirt 16wells/36wells/48wells/81wells/100wells3 refs Superfirt 1ml, 2ml, 5ml, 10ml, 25m,50ml,100ml3 refs Superfirt 1ul/10ul2 refs Superfirt 20ml,30ml, 40ml, 60ml, 80ml,90ml, 100ml, 120ml3 refs Superfirt 25ml,50ml,100ml,250ml,500ml,1000ml3 refs Superfirt 2X2”,2X3”,2X4”,2X10”,2X12”,2X20”, 3X3”, 3X4”, 3X5”,3X12”,3X20”,4X4”,4X5”,4X6”,4X7”,4X8”,4X10”, 5X5”,5X6”, 5X7”,5X8”, 5X10”, 6X4”,6X6”,6X8”, 6X9”, 6X10”,6X12”,8X8”,8X10”,8X12”, etc.3 refs Superfirt 30ml/60ml/250ml/500ml/1000ml/2500ml/5000ml3 refs Superfirt 35mm/60mm/70mm/90mm/100mm/120mm/ 130mm/150mm3 refs Superfirt 40wells /50wells/60wells/72wells/96wells3 refs Superfirt 5ml-5000ml Superfirt 6wells/12wells/24wells/48wells/96wells/384wells3 refs Superfirt Glass：1075mm/10100mm/1275mm/ 12120mm/1375mm/12100mm/16100mm/16150mm/ 16160/18180mm/18110mm/20150mm/ 25150mm/ 13100mm etc. Plastic: 10x50mm/10x60mm/12x60mm/1155mm/1275mm/12100/ 1375mm/13x100mm/13*150mm/15x100mm/15x150mm /16x100mm/ etc.3 refs	A IVDR	EUDAMED record Report an error
Haimen Shengbang Laboratory Equipment FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	0.2ml98/79 0.2ml , 0.5ml, 1ml , 2ml, 3ml , 3ml long , 5ml , 10ml 0.2ml, 0.5ml , 1.5ml, 2ml , 5ml , 7ml , 10ml, 15ml , 30ml, 50ml 0.5ml98/79 0.5ml , 1ml , 1.5ml, 1.8ml , 2ml , 3ml , 4ml , 5ml , 7ml , 10ml 15 others 0.5ml 1.5ml 2ml 15ml 50ml3 refs 1.8ml 2ml2 refs 10ul 200ul 1000ul3 refs 10ul, 20ul , 50ul, 100ul, 200ul , 300ul , 500ul , 1000ul, 1250ul, 5ml , 10ml 12x60mm, 12x75mm , 13x75mm, 12x100mm, 13x100mm , 15x100mm, 16x100mm , 16x102mm, 17x100mm, 16x125mm , 16x150mm 12x75mm 13x75mm 13x100mm 16x100mm 16x102mm3 refs 1ul98/79 250ml 500ml2 refs 25slides 50slides 100slides3 refs 40well 60well 90well3 refs 6 Hole98/79 60mm 65mm 90mm 90mm without vent 90mm double rooms 90mm three rooms 120x120mm square 150mm3 refs 81well 100well2 refs Pasteur Pipette 0.5ml98/79 Petri Dish Ф35mm98/79	A IVDR, 98/79	EUDAMED record Report an error
Pro-Lab Diagnostics EU representative : Advena Limited (Malta)	Canada	Microbank Blue98/79 Microbank Blue with 2D Barcodes98/79 Microbank Dry Blue98/79 Microbank Dry Green98/79 Microbank Dry Light Blue98/79 12 others Microbank Dry Mixed98/79 Microbank Dry Red98/79 Microbank Dry Yellow98/79 Microbank Green98/79 Microbank Green with 2D Barcodes98/79 Microbank Light Blue98/79 Microbank Light Blue with 2D Barcodes98/79 Microbank Mixed with 2D Barcodes98/79 Microbank Red98/79 Microbank Red with 2D Barcodes98/79 Microbank Yellow98/79 Microbank Yellow with 2D Barcodes98/79	– 98/79	Website support@pro-lab.com EUDAMED record Report an error
Vircell	Spain	ELISA SORBENT S0013 refs IFA IgA FITC-CONJUGATE C0005 IFA IgG FITC-CONJUGATE C0003 IFA IgM FITC-CONJUGATE C0004 IFA SORBENT S0022 refs 12 others SALIVA COLLECTION CONTAINER KIT TMO002 SERUM DILUENT FOR BRUCELLACAPT® B0002 SERUM DILUENT FOR ELISA KITS B0003 TRANSPORT MEDIUM TM3 refs TRANSPORT MEDIUM-2 TM23 refs Vircell, S.L SE001 VIRCLIA® AUXILIARY REAGENTS VCMAR VIRCLIA® AUXILIARY REAGENTS-DS VCMAR-DS VIRCLIA® AUXILIARY REAGENTS-EDB VCMAR-EDB VIRCLIA® AUXILIARY REAGENTS-EDP VCMAR-EDP VIRCLIA® AUXILIARY REAGENTS-W1 VCMAR-W1 WASH BUFFER FOR ELISA KITS B0001	A IVDR	EUDAMED record Report an error
Nantong Huayun Medical Equipment Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	0.2ml, 0.5ml, 1.5ml, 2ml, 5ml, 7ml, 10ml, 15ml, 50ml, 100ml3 refs 0.2ml（48wells, 60wells, 72wells, 96wells）/0.5ml(48wells, 60wells, 72wells, 96wells)/1.5ml(48wells, 60wells, 72wells, 96wells) /5ml(24wells, 32wells, 48wells, 60wells) and 15ml, 50ml 0.5ml/1ml/1.5ml/1.8ml/2ml/5ml/10ml2 refs 0.5ml/1ml/3ml/5ml/10ml 10ul, 20ul, 50ul, 100ul, 200ul, 300ul, 1000ul, 5000ul, 10ml 11 others 12mm/13mm/16mm/20mm 16wells/36wells/48wells/81wells/100wells 1place/2 Places/3places/ 5places/10places/12places//20places/25places/50places/100places 1ul/10ul 35mm/60mm/70mm/90mm/100mm/120mm/130mm/150mm 40wells /50wells/60wells/72wells/96wells 6wells/12wells/24wells/48wells/96wells/384wells Eppendorf 10ul, 20ul, 50ul, 100ul, 200ul, 300ul, 1000ul, 5000ul, 10ml2 refs Glass：1075mm/10100mm/1275mm/12120mm/ 1375mm/12100mm/16100mm/16150mm/ 16160/18180mm/18*110mm/ etc. Micro tube 0.5ml-1ml PET/Glass- Vacuum tube (1-10ml) PP/Non-Vacuum Tube (1-10ml) (Plain/ETDA K2/ETDA K3/Clot activator/ Gel and Clot Activator/Glucose/Lithium Heparin/Sodium Heparin/ESR tube/PT tube) Without Medium With Medium (Amies, Stuart, Cary Blair)	A IVDR	EUDAMED record Report an error
Jiangsu Kahotest Citotest Labware Manufacturing EU representative : SUNGO Europe B.V. (Netherlands)	China	0.2ml(96wells、100wells、153wells)/ 0.5ml(72wells、98wells)/1.5ml(72wells、100wells)/5ml(32wells)/0.5ml and1.5ml(60wells、96wells)/0.2-50ml/15ml/50ml 0.2ml/0.5ml/1.5ml/2ml/5ml/7ml/10ml/15ml/50ml/100ml 0.2ml/0.5ml/1ml/2ml/3ml/5ml/10ml 0.5ml/1ml/1.5ml/1.8ml/2ml/5ml/10ml 1 place/2 place/3 place/5 place/10 place/12 place/20 place /25 place/50 place/100 place 10 others 10ul(96wells)/200ul(96wells)/1000ul(60wells、100wells)/5ml(28wells)/ 10ml(15wells) 10ul/200ul/300ul/1000ul/5ml/10ml 12mm/13mm/16mm/40mm 12X75mm/13X75mm/12X100mm/13X100mm/15X100mm/16X100mm/16X102mm/16X125mm/16X150mm/40X200mm2 refs 13X165mm 16wells/36wells/49wells/81wells/100wells 1ul/10ul/1+10ul 35mm/60mm/70mm/90mm/100mm/120mm/130mm/150mm 40wells/50wells/60wells/90wells/66pillar 6wells/12wells/24wells/48wells/96wells/384wells	A IVDR	EUDAMED record Report an error
sebia FDA	France	"AUTOMATIC LOW VOLUME" LABELS FOR MINICAP FLEX-PIERCING (20) "MANUAL LOW VOLUME" LABELS FOR MINICAP FLEX-PIERCING (20) APPLICATOR BARCODE LABELS (500) FILTER PAPER COMBS 12 TEETH / 10 (5) FILTER PAPER COMBS 18 TEETH / 10 (5) 10 others FILTER PAPER COMBS 6 TEETH / 10 (5) FILTERS FOR CAPILLARYS / MINICAP SOLUTIONS (10) GEL BARCODE LABELS (500) HYDRAGEL APPLICATORS 15 (10) HYDRAGEL APPLICATORS 18 (10) HYDRAGEL APPLICATORS 6 (10) HYDRAGEL APPLICATORS 7 (10) HYDRASHIFT GREEN APPLICATORS 15 (10) THICK FILTER PAPERS / 10 (6) THIN FILTER PAPERS / 10 (6)	A IVDR	Website EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands)	China	Nucleic Acid Extraction Kit DA06003 refs Nucleic Acid Extraction Kit DA10003 refs Nucleic Acid Isolation or Purification Kit3 refs Nucleic Acid Isolation or Purification Reagent3 refs RNA/DNA Extraction or Purification Kit DA06403 refs 8 others RNA/DNA Extraction or Purification Kit DA06502 refs RNA/DNA Extraction or Purification Kit DA06603 refs RNA/DNA Extraction or Purification Kit DA12703 refs RNA/DNA Purification Kit (Magnetic Bead) DA06303 refs RNA/DNA Purification Kit (Preservation) DA09403 refs RNA/DNA Purification Kit (Preservation/Release) DA0960 RNA/DNA Purification Kit (Release) DA09503 refs RNA/DNA Purification Kit (Spin Column)2 refs	A IVDR	EUDAMED record Report an error
Biotecnica	Italy	Capsula portasiero 667.10402 refs Cuvette Wash Solution3 refs CV% SOLUTION DETERG. CAMERA MISCELAZIONE Extra Wash solution3 refs 6 others FCC SOLUTION TARGA ISE Enzymatic solution3 refs ISE Wash Solution3 refs Multi-Cleaning Solution3 refs NA CONDITIONING SOLUTION2 refs TENSIOATTIVO3 refs	A IVDR	EUDAMED record Report an error
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands)	United States	10% Neutral Buffered Formalin3 refs Acrytol3 refs ActivFlo Biopsy II, Taped, Orange3 refs APEX SUPERIOR ADHESIVE SLIDE - BLUE3 refs Biopsy Bags3 refs 5 others Blue Ribbon3 refs Frostbite FSC22 Blue Frozen Section Compound3 refs HistoCore Spectra CV Cover Glass3 refs LP Biopsy I Cassettes, Blue3 refs	A IVDR	Website EUDAMED record Report an error
Giesse Diagnostics	Italy	Hitergent 3939/4 Soluzione Deproteinizzante 3934 Soluzione di lavaggio "extra" 3972 Soluzione di lavaggio 3930 Soluzione di lavaggio Cleanser 3900 4 others Soluzione di lavaggio concentrata (Ratio 1:5) 3931/4 Soluzione di lavaggio speciale 3933 Soluzione di sistema (1:10001) - "Rinse" 3973 Tensioattivo concentrato 3970	A IVDR	Website info@giessediagnostics.com EUDAMED record Report an error
Jinquanmedical EU representative : SUNGO Europe B.V. (Netherlands)	China	JQD1-QXA-A，JQD1-QXB-A，JQD8-QXA-A，JQD8-QXB-A JQD2-SMA-A，JQD2-SMB-A JQD3-FLA-A，JQD3-FLB-A JQD4-YHA-A，JQD4-YHB-A JQD5-TLA-A，JQD5-TLB-A 3 others JQD6-HCA-A，JQD6-FHB-A JQD7-QXA-A，JQD7-HCB-A JQDX-FPA-A，JQDX-FPB-A	A IVDR	sales1@jinquanmedical.com EUDAMED record Report an error
Leadmanbio EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Concentrated Wash Solution 2.5L Immunodiagnostic Products Signal Reagent 500mL Sample Diluent 1 30mL Sample Diluent 2 30mL Sample Diluent 3 30mL 3 others Sample Diluent 4 30mL Sample Diluent 5 30mL Wash Solution 10L	A IVDR	EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Medunion S.L. (Spain) and 1 other	China	Access Substrate 130mL×4 Chemiluminescence Reaction Vessel 1000 PCS *8 packs/box Daily Maintenance Solution 35mL×2 Disposable Sample Cups 1000 pieces/bag of 0.5mL Fecal Staining Solution 100 mL/bottle 3 others Sample Probe Wash Buffer 2.5L×2 System Check Solution 10mL×4 Wash Buffer 10L	A IVDR	Website info@orienterglobal.com EUDAMED record Report an error
I.S.E. - Societa' A Responsabilita' Limitata - Sistemi Intelligenti Elettronici	Italy	Hemo One+, Soluzione Rinse Ew Prb3 refs Multiclean solution for Hemo One 1x1000 Soluzione cleaner per Miura 2 Lt2 refs Soluzione cleaner per Miura 2x100ml Soluzione Rinse Ew Cvt per Miura 6x35ml2 refs 2 others Soluzione Rinse NEW cvt per Miura 6x35ml2 refs Soluzione sistemica 20x1Lt3 refs	A IVDR	Website info@logotech-ise.com EUDAMED record Report an error
Nantong Rightips Medical Technology EU representative : Sungo Cert GmbH (Germany)	China	0.2ml98/79 0.5ml98/79 10ml98/79 10ul98/79 1ul98/79 2 others 6 Hole98/79 Φ35mm98/79	– 98/79	EUDAMED record Report an error
Denizbiyokimya	Türkiye	INNOVIQURE Assay Cup98/79 INNOVIQURE Enhanced Wash Buffer98/79 INNOVIQURE preTrigger Solution98/79 INNOVIQURE Trigger Solution98/79 INNOVIQURE Wash Buffer98/79 1 other R2D2-In Timer98/79	– 98/79	EUDAMED record Report an error
Haimen Rotest Labware Manufacturing EU representative : SUNGO Europe B.V. (Netherlands)	China	0.2ml/ 0.5ml/ 0.6ml/1.5ml/2ml/5ml/7ml/ 10ml/15ml/20ml/30ml/ 50ml/80ml/ 100ml 0.5ml/0.75ml/1ml/1.5ml/1.8ml/2ml/3ml4ml/5ml/ 7ml/10ml/15ml/50ml 10ul/20ul/30ul/50ul/100ul/200ul/300ul/500ul/1000ul/1250ul/5ml/10ml 1ul/10ul 35mm/55mm/60mm/65mm/70mm/ 90mm/100m/120mm/130mm/150mm/250mm 1 other 5ml/6ml/10ml/12ml/15ml/20ml/12x60/12x75/ 13x75/13x78/13x100/15x100/16x100/16x102/ 16x150	A IVDR	export@hmrotest.com EUDAMED record Report an error
Jiangsu Confidence Medical Technology EU representative : JOYSUN GROUP S.L.U (Spain)	China	Automatic Chemiluminescence Immunoassay Analyzer KDS-F1600\ KDS-F2600\ KDS-F3600\ KDS-F6600\ KDS-F8800\ KDS-F9900 Excitation liquid/pre excitation liquid2 refs Portable automatic multifunctional analyzer KDS-D5000\ KDS-D6000\ KDS-D8000 Reaction cup Sample diluent 1 other Test substance cleaning solution2 refs	A IVDR	EUDAMED record Report an error
Jinan Lanjie Biotechnology EU representative : MedPath GmbH (Germany)	China	Hematology Analysis Diluent Hematology Analysis Lyse Hematology Analysis Staining Solution 48mL Urinalysis Diluent Urinalysis Sheath Fluid 20L 1 other Urinalysis Staining Solution 29ml	A IVDR	EUDAMED record Report an error
Ningbo Konfoong Bioinformation Tech EU representative : Share info GmbH (Germany)	China	KFBIO KF-CTPF-20L KFBIO KF-EASL-25L KFBIO KF-HTSL-24L KFBIO KF-SLBF-22S KFBIO KF-SPMD-21L 1 other KFBIO KF-WHBF-23L	A IVDR	Website EUDAMED record Report an error
Realmindbio EU representative : Sungo Cert GmbH (Germany)	China	1×1000 mL/ bottle 2×3 mL/ bottle 96 pcs/kit. Model: 1×, 10×. Specifications: 1×10 L/ pail, 1×1000 mL/ bottle.2 refs Model: D001,D002,D003,D004,D005,D006,D007,D008,D009,D010,D011,D0123 refs 1 other Trigger Solution 1: 1×250 mL/ bottle, Trigger Solution 2: 1×250 mL/ bottle	A IVDR	EUDAMED record Report an error
Benoylab EU representative : SUNGO Europe B.V. (Netherlands)	China	0.2ml, 0.5ml, 1.5ml, 2ml, 5ml, 10ml, 15ml, 50ml 10ul,0.1ml,0.2ml,0.5ml,1ml,2ml,3ml,5ml,7ml,10ml 10ul,200ul,1000ul 12x75mm,13x75mm,16x100mm 60x15mm,90x15mm,100x15mm	A IVDR	Sale02@benoylab.com EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Acid Cleaning Solution 2L（93004） Alkaline Cleaning Solution 2L（93002） Alkaline Cleaning Solution C 60ml×2（93005）3 refs E-Z Cleaning Solution 100mL（10105） Probe Cleaning Solution Ⅱ 50mL（10109）2 refs	A IVDR	EUDAMED record Report an error
Jiangsu Yuli Medical Instrument EU representative : Sungo Cert GmbH (Germany)	China	ESR tube rack; plastic test tube rack; aluminium test tube rack; stainless steel test tube rack with different sizes Glass tube；PS tube；PET tube；PE tube；PP tube；Centrifuge tube；Urinary sediment tube；Cryo tube；PCR tube One room petri dish；Grid petri dish；Two room petri dish；Three room petri dish；Four room petri dish with different sizes Pipette tip with filter；Pipette tip without filter；Pasteur pipette with different sizes pipette tips Storage box；slide storage box；centrifuge tube storage box；cryo tube storage box；Cryogenic storage box for blood collection tube；Embedding Cassette	A IVDR	EUDAMED record Report an error
Kangrun EU representative : Sungo Cert GmbH (Germany)	China	Cleaning Solution CK-XY-003 Sample Diluent2 refs Sample Releaser Reagent3 refs Substrate Solution CK-DW-0072 refs System maintenance type.	A IVDR	EUDAMED record Report an error
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands)	China	Fluorescent Internal Standard Dyes2 refs Nucleic Acid Extraction or Purification Kit2 refs Nucleic Acid Extraction or Purification Kit XB03076 Nucleic Acid Extraction or Purification Kit XB16028 Polymer Gel A01010012	A IVDR	EUDAMED record Report an error
Taizhou Kangwei Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands)	China	0.1ml,0.2ml, 0.5ml,1ml,1.8ml, 1.5ml, 2ml, 5ml, 7ml, 10ml, 15ml,16ml,20ml,25ml,30ml,35ml, 50ml, 100ml,120ml,150ml,250ml,280ml,300ml,375ml500ml,550ml, 750ml,600ml, 450ml,1000ml,850ml,1200ml,1800ml,2400ml3 refs 10ul, 20ul, 50ul,100ul,200ul, 250ul,300ul,1000ul,1250ul, 5000ul, 10ml3 refs 25mm/35mm/55mm/60mm/70mm/75mm/90mm/100mm/120mm/130mm/150mm/250mm3 refs 5ul/10ul/15ul/20ul/25ul/40ul/50ul/60ul/70ul/80ul/100ul/120ul/150ul/155ul/200ul/300ul/400ul/500ul/600ul/0.1ml/0.2ml/0.5ml/1ml/2ml/3ml/5ml/10ml/15ml/20ml/25ml/50ml/100ml 7150mm/7230mm/890mm/8100mm/8120mm/8150mm/8180mm/8200mm3 refs Glass:1075mm/10100mm/1260mm/1275mm/12120mm/ 1375mm/1378mm/13100mm/12100mm/16100mm/15100mm/15150mm/16150mm/16160mm/18180mm/18110mm/20150mm/25150mm/ 13100mm /30200mm/25200mm/20200mm etc3 refs	A IVDR	EUDAMED record Report an error
Virtue Diagnostics (Suzhou) EU representative : Kingsmead Service B.V. (Netherlands)	China	Concentrated Wash Buffer2 refs Pre-Trigger Solution2 refs Sample Diluent A2 refs System Maintenance Fluid Trigger Solution2 refs	A IVDR	EUDAMED record Report an error
Zhejiang xinke Medical Technology EU representative : Sungo Cert GmbH (Germany)	China	Buffer3 refs CLEANING SOLUTION3 refs HEMATOLOGY ANALYSIS DILUENT3 refs HEMATOLOGY ANALYSIS LYTIC AGENT3 refs HEMATOLOGY ANALYSIS STANING SOLUTION3 refs	A IVDR	EUDAMED record Report an error
Arcdia	Finland	mariPOC® Gastro sample buffer mariPOC® RTI sample buffer mariPOC® System solution mariPOC® Wash solution	A IVDR	Website office@arcdia.com EUDAMED record Report an error
Innodx EU representative : QbD RepS BV (Belgium)	China	Concentrated Wash Solution2 refs Diluent Universal3 refs Pre-trigger Solution2 refs Trigger Solution2 refs	A IVDR	Website EUDAMED record Report an error
Kangmei Tianhong Biotech (Beijing) EU representative : Lotus NL B.V. (Netherlands)	China	DNA &RNA Purification Kit For MagMaX 20 Tests/kit98/79 DNA &RNA Purification Kit For MagMaX 64 Tests/kit98/79 DNA/RNA Extraction Kit(Magnetic beads method) 20 Tests/kit98/79 DNA/RNA Extraction Kit(Magnetic beads method) 64 Tests/kit98/79	– 98/79	Website info@kindmay.com EUDAMED record Report an error
Nantong Yuanyi experimental Equipment EU representative : SUNGO Europe B.V. (Netherlands)	China	0.1ml 0.2ml 0.5ml 1.5ml 2ml 5ml 7ml 10ml 15ml 25ml 30ml 50ml 100ml 120ml 150ml 0.5ml 1.0ml 1.5ml 1.8ml 2ml 5ml 10ml 15ml 10ul 20ul 50ul 100ul 200ul 250ul 300ul 500ul 800ul 1000ul 1250ul 1500ul 5000ul 10000ul 35mm 60mm 65mm70mm 75mm 80mm 90mm 90mm-2room 90mm-3room 90mm-4room 100mm 120mm 150mm 100100mm 130130mm 150*150mm	A IVDR	EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Cell Preservation Solution N3003B Nucleic Acid Extraction Reagent (Magnetic beads) N3002C Nucleic Acid Extraction Reagent (Magnetic beads) N3002D Nucleic Acid Extraction Reagent N3001B	A IVDR	EUDAMED record Report an error
Sorfa FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	0.2ml; 0.5ml；1.5ml；2ml，5ml，15ml，50ml，225ml，250ml,500ml 5μl, 10μl, 20μl, 100μl, 200μl, 300μl l, 500μl, 1000μl, 1250μl L601, L602, L603, L610 P101,P102,P105,P106,P107,P108,P109,P110,P111,P112,P113,P114,P116,P117,P118,P119,P120,P121,P122,P123,P124,P125,P126,P129,P201,P202,P205,P206,P207,P208,P210,P211,P212,P213,P301,P302,P303,P304,P305,P306,P307,P308,P309,P310,P401,P402,P403,P404,etc	A IVDR	EUDAMED record Report an error
Taizhou Zecen Biotech EU representative : MedPath GmbH (Germany)	China	Acidic Biochemical Cleaning Solution 1000mL/bottle3 refs Sample Dilution 72 refs Substrate 1000mL/bottle3 refs System Washing Solution 1000mL/bottle3 refs	A IVDR	EUDAMED record Report an error
Boen Healthcare FDA EU representative : Everbiz GmbH (Austria)	China	INOCULATION LOOPS SPACER FOR AEROSOL Syringe Filter	A IVDR	Website EUDAMED record Report an error
CellPath FDA EU representative : Emergo Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	BITRAN® BAG 12 INCH x 12 INCH (300x300mm)3 refs CYTOFIXX DROPPER - 50ml - CYTOLOGICAL FIXATIVE3 refs XTF CLEARING AGENT - 5L3 refs	A IVDR	Website info@cellpath.com EUDAMED record Report an error
Chengwumedical EU representative : SUNGO Europe B.V. (Netherlands)	China	1260mm、1275mm、1375mm、12100mm、13100mm、15100mm、16100mm、 16102mm、 17100mm3 refs 30x15mm,35x15mm,55x15mm,60x15mm,65x15mm,90x15mm,130x15mm,150x15mm,single room, double room3 refs Gilson：10ul、200ul、1000ul、5000ul、10000ul Eppendorf：10ul、200ul、300ul、1000ul、10000ul Oxford：200ul、1000ul MLA：200ul、1000ul Qiujing：449、4#、500ul Dalong：5ml3 refs	A IVDR	EUDAMED record Report an error
EntroGen FDA EU representative : TANJA TOPOVSEK S.P. (Slovenia)	United States	Library Prep Purification Kit NGS Adapter Kit for Illumina® NGS Library Prep Kit For Illumina®	A IVDR	Website contact@entrogen.com EUDAMED record Report an error
Genekam	Germany	SB0001-Genekam Universal DNA-Isolation Kit (INT) SB0079-Genekam Universal RNA-Isolation Kit (INT) SB0179-Genekam Universal DNA/RNA-Isolation Kit (INT)	A IVDR	Website office@genekam.de EUDAMED record Report an error
Genfollower EU representative : SUNGO Europe B.V. (Netherlands)	China	Centrifuge tubes：CTB15YE, CTB50, CTB50YE, CTF15, CTF15YE, CTF50, B-CTB15, B-CTB50, B-CTF15, B-CTF50, B-CTB15RE-1, B-CTB50RE-1, B-SCTB50RE-1, B-2SCTB50RE-1, B-CTB15BL-N, B-CTB50BL-N, B-SCTB50BL-N, B-2SCTB50BL-N, B-CTB50YE-1, B-CTB15BL, etc Culture tubes:STBP05, STBS05, STFP05, STFS05, STBP12, STBS12, STFP12, STFS12, UT00001, UT00002, UT10001, UT10002, UT10003, UT00003, UT00004, Inoculating needles:CZ00001, etc PCR 8 strips:PCR8WC-02TN, PCR8WC-02BN, PCR8WC-02N , B8RT-02N, B8RT-02W, B8LT-01N, B8LT-01W, PCR-B8GC, B8LT5-01W, PCR5-B8GC, B8RT5-02W, PCR-A8TC, A8LT-01N&PCR-A8GC, A8LT-01W&PCR-A8GC, A8RT-02N&PCR-A8GC, etc	A IVDR	EUDAMED record Report an error
Jiangsu Comeon Medical Apparatus EU representative : Sungo Cert GmbH (Germany)	China	Centrifugal tube Freezing tube Suction head	A IVDR	EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CMPure Beads2 refs CWseq Universal DirectFast DNA Library Prep Kit (Illumina & MGI)2 refs CWX401S/M2 refs	A IVDR	EUDAMED record Report an error
Labmediaservis	Czechia	Fyziologický roztok3 refs Fyziologický roztok pufrovaný3 refs Fyziologický roztok s glukózou2 refs	A IVDR	Website info@labmediaservis.cz EUDAMED record Report an error
Lituo EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Cell Counting Plate Type I, Type II LTC2901013 refs Immersion Oil2 refs Mixing Plate LTF150101	A IVDR	Website EUDAMED record Report an error
Ningbo Trustlab Instruments EU representative : Lotus NL B.V. (Netherlands)	China	Cryo tube 2ml Micro Centrifuge Tube 1.5ml Multi-purpose tube rack GT203-8162 refs	A IVDR	EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA Centaur Disposable Sample Tips IVDR_67_TTN_DUB-C_A_INST_Sample Probe Tip ADVIA Centaur Systems Cuvette IVDR_67_TTN_DUB-C_A_INST_Cuvette Dimension Vista® Small Sample Container (SSC) IVDR_67_GLA_DUB-C_A_INST_Small Sample Container	A IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Trustmomed EU representative : Sungo Cert GmbH (Germany)	China	TM219-001,TM219-002,TM219-003,TM219-004,TM219-005,TM219-006, TM219-007,TM219-008,TM219-009,TM219-010,TM219-011,TM219-012, TM219-013,ect TM224-001, TM224-002, TM224-003, TM224-004, TM224-005, TM224-006, TM224-007, TM224-008, TM224-009, TM224-010, TM224-011, TM224-012, TM224-013, TM224-014, TM224-015, TM224-016, etc TM236-001,TM236-002,TM236-003,TM236-004,TM236-005,TM236-006, TM236-007,TM236-008,TM236-009,TM236-010,TM236-011, etc	A IVDR	sales@trustmomed.com EUDAMED record Report an error
YD Diagnostics FDA EU representative : CARE diagnostica Laborreagenzien GmbH (Germany)	South Korea	URiSCAN PluScope Cleanser98/79 URiSCAN PluScope Reagent A98/79 URiSCAN PluScope Reagent B, URiSCAN PluScope ver2 Reagent B98/79	– 98/79	Website admin@yd-diagnostics.com EUDAMED record Report an error
Zhejiang Rongda Bio Technology EU representative : Sungo Cert GmbH (Germany)	China	430010, 430011, 430200, 430201, 430301, 431000, 431001, 431250, 460010, 460011, 460200, 460300, 461000, 461250, 440010, 440011, 440200, 440201, 440301, 441000, 441001, 441250, 450010, 450011, 450200, 450300, 451000, etc 661200, 661201, 661202, 661203, 661204, 661205, 661206, 671200, 671201, 671202, 671203, 671204, 671205, 671206, 662200, 662201, 662202, 662203, 662204, 662205, 662206, 672200, 672201, 672202, 672203, etc 720001, 720002, 720005, 720010, 720025, 720050, 720100, 721001, 721002, 721005, 721010, 721025, 721050, 721100, 710001, etc	A IVDR	EUDAMED record Report an error
Beijing Wantai DRD EU representative : QbD RepS BV (Belgium)	China	Acid Wash Solution Alkaline Wash Solution	A IVDR	EUDAMED record Report an error
Bioteke FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	AU1001-2,AU1001-3,AU1001-53 refs BTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00"3 refs	A IVDR	Website info@bioteke.cn EUDAMED record Report an error
Cangzhou Shengfeng Plastic Product EU representative : SUNGO Europe B.V. (Netherlands)	China	"0.3ml;0.5ml;0.8ml;1ml;1.25ml;1.5ml;2ml;2.5ml;3ml;4ml;5ml;7ml;8ml;10ml;15ml;20ml;25ml;30ml;40ml;50ml;60ml;80ml;100m;125ml;150ml;170ml;200ml;250ml;300ml;400ml; 500ml;600ml;800ml;1000ml;1.5L;2L;2.5L;3L;4L;5L;10L;15L;20L 3ml; 5ml; 10ml;15ml;20ml;30ml;50ml;100ml;200ml;300ml;500ml;1000ml;2000ml	A IVDR	EUDAMED record Report an error
Citotest FDA EU representative : Wellkang Ltd (Northern Ireland)	China	CITOGLAS6 refs CITOTEST5 refs	A IVDR	Website info@citotest.com EUDAMED record Report an error
Diatron FDA	Hungary	5x TBS Wash Buffer TWB56 Additive for wash solution VA0000SL3 refs	A IVDR	Website EUDAMED record Report an error
e-LinkCare Meditech FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	UBREATH TF711,TF721，TF7713 refs UBREATH TF731，TF7812 refs	I MDR	EUDAMED record Report an error
Guangzhou LBP Medicine Science & Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	"Series A(100tests/box) Series B(100tests/box) Series C(100tests/box) Series D(100tests/box) "3 refs 200 tests/box2 refs	A IVDR	EUDAMED record Report an error
Hangzhou HealthSky Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	FCP-5T Healthsky FCS-4A FCS-4B2 refs	A IVDR	EUDAMED record Report an error
Integrated DNA Technologies FDA EU representative : Integrated DNA Technologies B.V. (Belgium)	United States	FUSIONPlex™-HT Dx Reagents 24rxn - A FUSIONPlex™-HT Dx Reagents 96rxn - A3 refs VARIANTPlex™-HT Dx Reagents 24rxn - A VARIANTPlex™-HT Dx Reagents 96rxn - A3 refs	A IVDR	Website EUDAMED record Report an error
Jiangsu Kehua Medical Instrument Technology FDA EU representative : Sungo Cert GmbH (Germany)	China	50μL,60μL,70-2000μL 50μL,60μL,70μL-2000μL	A IVDR	info@jskehua.cn EUDAMED record Report an error
Mandelab EU representative : SUNGO Europe B.V. (Netherlands)	China	"MT-DTM001,MT-DTM002； MT-HTM001,MT-HTM002； MT-IVT001,MT-IVT002,MT-SVT001,MT-SVT002； MT-CTM001； MT-LAT001,MT-LAT002； MT-FTM001,MT-FTM002,MT-FTM003；" MSK-HSK001,MSK-HSK002, MSK-HSK003,MSK-HSK004,MSK-HSK005,MSK-HSK006	A IVDR	EUDAMED record Report an error
mti-diagnostics Gesellschaft für medizinische und technische Investionsprojekte mbH	Germany	Alkaline Detergent for Urit analyzer (1 x 1L) Multiclean2 refs	A IVDR	Website info@mti-diagnostics.com EUDAMED record Report an error
Nantong Mevid Life Scientific EU representative : Sungo Cert GmbH (Germany)	China	HE03-2001,HE03-2002,HE03-2003,HE03-2004 PW01-5658,PW01-5860	A IVDR	EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Incubator RT-A19 Incubator Shaker RT-A29	A IVDR	Website support@rayto.com EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany)	China	Hematology Reagent Kit HVG-3: 5 tests/box, 10 tests/box, 20 tests/box, 50 tests/box, 100 tests/box.98/79 Hematology Reagent Kit HVG-5：5 tests/box, 10 tests/box, 20 tests/box, 50 tests/box, 100 tests/box98/79	– 98/79	Website service.channel@szchenna.com EUDAMED record Report an error
Taizhou Huangyan Fangye Technology Development EU representative : Sungo Cert GmbH (Germany)	China	0.5ml 8 well	A IVDR	EUDAMED record Report an error
Themis Pathology	Romania	Lumea BxBoard LUMEA BxChip3 refs	A IVDR	Website EUDAMED record Report an error
Wuxi NEST Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Cryogenic Vial Pasteur pipette	A IVDR	EUDAMED record Report an error
Yiguoren EU representative : BioDomi GmbH (Germany)	China	Microscope Slides QP-01、SP-01、QP-02、SP-02、QJ-03、SJ-03 Plastic Consumables For Medical Laboratories ZP11、ZP12、ZP15、ZP20、ZP25、ZP30	A IVDR	EUDAMED record Report an error
Yiwu City Ange Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands)	China	Pipette tips 10ul、20ul、 50ul、100ul、200ul、300ul、1000ul、5000ul、10000ul Test Tube 1075mm/10100mm/1260/mm1275mm/12100mm/12120mm/1375mm/15×100mm 15×150mm/16100mm/16*150mm/18x180mm/20x150mm/20x200mm/25×200mm/30x20mm /40×200mm/1.5mL、2mL、5mL、10mL、15mL、20ml、25ml、50mL	A IVDR	EUDAMED record Report an error
Yiwu Eason Medical Devices EU representative : SUNGO Europe B.V. (Netherlands)	China	koumd Blue Pipette Tip For Eppendorf Molded Graduated 1000ul Blue/Yellow/White Pipette Tip For Eppendorf 1000ul/200ul/300ul/10ul/5ul etc3 refs koumd Plastic Test Tube 3mlΦ1260ps,5mlΦ1275pp,5mlΦ1375pp,5mlΦ1275ps,5mlΦ1375ps,7mlΦ12100ps,7mlΦ13100ps,10mlΦ15100pp,10mlΦ16100pp,10mlΦ16102ps3 refs	A IVDR	EUDAMED record Report an error
Accucise EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	6×380 mL; 4×500 mL; 2×2 L6 refs	A IVDR	sales@accucise.cn EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark)	United States	GenetiSure Dx Cot-1 Human DNA3 refs	A IVDR	Website info.dk@agilent.com EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium)	China	Label paper	A IVDR	Website EUDAMED record Report an error
Avantech EU representative : SUNGO Europe B.V. (Netherlands)	China	ICT-200S-R、ICT-200S-G、ICT-200S-Y、ICT-200S-W、ICT-200S-V、ICT-200S-B、ECT-160S-R、ECT-160S-G、ECT-160S-Y、ECT-160S-W、ECT-160S-V、ECT-160S-B、ECT-050-R、ECT-050-G、ECT-050-Y、ECT-050-W、ECT-050-B、ECT-150-R、ECT-150-G、ECT-150-Y, etc.	A IVDR	EUDAMED record Report an error
Beyotime EU representative : SUNGO Europe B.V. (Netherlands)	China	250ml	A IVDR	EUDAMED record Report an error
Bgi	Denmark	BGI 960 tests/kit	A IVDR	Website EUDAMED record Report an error
Biocytech Sdn Bhd FDA EU representative : SUNGO Europe B.V. (Netherlands)	Malaysia	PathTezt Sedprep Syatem (10) 1. L-30 2. LJ-30 3. LBP-2010 4. LBP-20123 refs	A IVDR	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruCell2 refs	A IVDR	EUDAMED record Report an error
BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands)	China	Cleaning Solution Composite Type3 refs	A IVDR	EUDAMED record Report an error
Bradley Products EU representative : Advena Limited (Malta)	United States	Davidson Marking System3 refs	A IVDR	Website EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany)	China	Cowingene Sample Diluent Reagent2 refs	A IVDR	Website EUDAMED record Report an error
Dakewe FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Paraffin Wax	A IVDR	Website EUDAMED record Report an error
Fluxergy FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Fluxergy Respiratory Specimen Collector2 refs	A IVDR	Website info@fluxergy.com EUDAMED record Report an error
Guangzhou Huayue Keju Biotech EU representative : SUNGO Europe B.V. (Netherlands)	China	HuayueKeju A: Disposable suction nozzle (5ml), 200 pieces/pack; B: Disposable straw 3ml, 100 tubes/pack; C: Disposable centrifuge tube (10ml), 200 tubes/pack; D: Disposable centrifuge tube 50ml, 50 pieces/pack; E: Disposable production cabin, etc.3 refs	A IVDR	EUDAMED record Report an error
Hangzhou Agen Biotechnology EU representative : SUNGO Europe B.V. (Netherlands)	China	P-2.2-SQ-96，P-2.2-SQG-96，P-2.2-SQV-96，P-2.2-SQVT-96，P-0.8-SQV-96，P-0.5-SQV-96，P-1.0-SQV-96，P-1.0-SQ-96，P-1.6-SQ-96，P-1.6-SQV-96，P-2.3-SQV-96，etc3 refs	A IVDR	EUDAMED record Report an error
Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Şi̇rketi̇	Türkiye	HOSMED PATHGYNE Lam	A IVDR	EUDAMED record Report an error
Hospitex	Italy	Citocamera monouso 8 ml ad Innesto Rapido - 100 pz	A IVDR	Website info@hospitex.com EUDAMED record Report an error
Hunan Biojoint Instrument EU representative : SUNGO Europe B.V. (Netherlands)	China	Hunan Biojoint Instrument Co.,Ltd 0.1ml ,0.2ml, 1.5ml, 2ml,5ml,10ml,15ml,50ml, DS20,DR20,P60A,P30A,P20A,P15A,P10A, CS3 refs	A IVDR	info@bio-joint.com EUDAMED record Report an error
Hunan Xiang Yi Laboratory Instrument Development FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	cence F-12K, F-24K, F-36K, MG2020, MG2040, BMG2024, VG10K, XY10S3 refs	A IVDR	EUDAMED record Report an error
Incyto FDA EU representative : MedNet EC-REP GmbH (Germany)	South Korea	INCYTO C-Chip3 refs	A IVDR	Website sales@incyto.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Sputasol 4×100mL/kit2 refs	A IVDR	marketing@hongweitest.com EUDAMED record Report an error
Jiangsu Rongye Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Test tube 12*75mm, 5ml PS2 refs	A IVDR	EUDAMED record Report an error
Joint	Italy	RILEVA98/79	– 98/79	Website info@joint-biomateriali.it EUDAMED record Report an error
Jungbrunnen Fountain of Youth	Germany	VHC Vitamin D98/79	– 98/79	Website info@jungbrunnenfoy.de EUDAMED record Report an error
Laboratory Of America Holdings EU representative : European Healthcare & Device Solutions Ltd. (Ireland)	United States	TruSight Oncology 500 LDT Assay (TS0500)98/79	– 98/79	Website EUDAMED record Report an error
Medical Wire & Equipment Bath EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Wire microloop3 refs	A IVDR	Website info@mwe.co.uk EUDAMED record Report an error
Munkplast	Sweden	07983	A IVDR	Website info@munkplast.se EUDAMED record Report an error
Ophiomics	Portugal	HepatoPredict98/79	– 98/79	Website quality@ophiomics.com EUDAMED record Report an error
Orgentec	Germany	Stool Extraction Medium F5126	A IVDR	Website EUDAMED record Report an error
PentaBase	Denmark	BaseSNAP™ Sensitive Nucleic Acid Purification Kit3 refs	A IVDR	Website info@pentabase.com EUDAMED record Report an error
RAM THz Solutions	Germany	ThEA Diagnostic Sensor Stick-F1 DSS-F198/79	– 98/79	Website info@ramthzsolutions.com EUDAMED record Report an error
Richard-Allan Scientific EU representative : Epredia Netherlands B.V. (Netherlands)	United States	Disposable Base Molds3 refs	A IVDR	EUDAMED record Report an error
Serosep FDA	Ireland	EntericBio® Stool Preparation Solution EBSPSA-v2	A IVDR	Website info@serosep.com EUDAMED record Report an error
Shandong Chengwu Ronghua Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	DNA Preservation Card3 refs	A IVDR	EUDAMED record Report an error
Shandong Junteng Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Coverslipping Film	A IVDR	EUDAMED record Report an error
Shanghai Bize Import Export EU representative : SUNGO Europe B.V. (Netherlands)	China	SH-170306; SH-170307; SH-170308; SH-170309	A IVDR	info@bizemed.com EUDAMED record Report an error
Stemcell FDA EU representative : MDSS GmbH (Germany)	Canada	SepMate™-15 854152 refs	A IVDR	Website EUDAMED record Report an error
Targetingone EU representative : SUNGO Europe B.V. (Netherlands)	China	Microfluidic chip 96 tests/box	A IVDR	EUDAMED record Report an error
Tharmac	Germany	GynoPrep Selfsampling Set	A IVDR	Website info@tharmac.de EUDAMED record Report an error
Yancheng Jufan Lab Instrument EU representative : SUNGO Europe B.V. (Netherlands)	China	Glass: 1075mm, 10100mm, 1275mm, 12120mm, 1375mm, 12100mm, 16100mm, 16150mm, 16160, 18180mm, 18110mm, 20150mm, etc	A IVDR	EUDAMED record Report an error
Zhejiang Aicor Medical Technology FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	AICOR6 refs	A IVDR	EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium)	China	LP3 refs	A IVDR	PMS@zy-ivd.com EUDAMED record Report an error
Chemclin EU representative : MedNet EC-REP GmbH (Germany) No model still on the market	China	LiCA LS Solution 2 × 105 mL; 4 × 45 mL; 6 × 18 mL3 refs (no longer marketed) LiCA PM Solution 4 × 45 mL (no longer marketed) LiCA Probe Cleaner (V1) 6 × 5 mL (no longer marketed) LiCA Specimen Diluent SD1; SD2 (no longer marketed)	A IVDR	Website EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) No model still on the market	China	Reaction Tube With Cap 0.2 ml single 0.2ml 8 strips98/79 (no longer marketed)	– 98/79	qa@egens-bio.cn 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) 51

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
Anaerobe Systems	United States	PRAS Dilution Blanks PRAS Reinforced Clostridial Broth (RCB) PRAS Peptone Yeast Extract Broth w/ Glucose (PYG) PRAS Peptone Yeast Extract Broth (PY) PRAS Thioglycollate Broth (THIO) PRAS Peptone Yeast Extract Broth w/ Adonitol (PY ADONITOL)	K841221 (1984)
SAKURA FINETEK U.S.A., INC. Present in Europe in other categories	United States	Tissue-Tek Xpress® x120 Tissue-Tek Xpress® x50 Tissue-Tek Xpress® Tissue-Tek® Tissue-Tek® Quick-Ray™ Tissue-Tek® NanoMold™	registered
PRO-LAB, INCORPORATED Present in Europe in other categories	Canada	Microbank Dry - Blue (80 vials) Microbank Green (80 vials) Microbank (with 2D Barcodes)-Red (80 vials) Microbank (with 2D Barcodes) -Blue (80 vials) Microbank (with 2D Barcodes)-Yellow (80 vials) Microbank Light Blue (80 vials)	registered
AnalytiChem USA, Inc.	United States	Redipor Cell Pro	registered
HARDY DIAGNOSTICS	United States	–	registered
Affymetrix, Inc. Present in Europe in other categories	United States	Affymetrix Applied Biosystems Affymterix	registered
Oxoid U.S.A., Inc. Present in Europe in other categories	United States	TRYPTONE SOYA BROTH SALINE TABLETS RINGERS SOLUTION TABLETS (100'S) HEART INFUSION BROTH BRAIN HEART INFUSION BROTH NUTRIENT BROTH	K822665 (1982)
Jiaoyue Pharmaceuticals (Huizhou) Co., Ltd.	–	JIAOYUE personal lubricant	registered
Dakewe (Shenzhen) Medical Equipment Co., Ltd.	China	Embedding Cassette	registered
Becton, Dickinson & CO Present in Europe in other categories	United States	BD BBL™ Brain Heart Infusion BD BBL™ Nutrient Broth	registered
EDGE BIOLOGICALS, INC.	–	EDGE BIOLOGICALS INC	registered
bioMerieux, Inc. Present in Europe in other categories	United States	API® 50 CH API® 50 CHB/E Medium API® 50 CHL Medium	registered
Remel Co. Present in Europe in other categories	United States	Sensititre Supplemental Brucella Broth	registered
BIO-OPTICA MILANO SPA Present in Europe in other categories	Italy	–	registered
BIOGENEX LABORATORIES	United States	–	registered
Biolog Inc	United States	–	registered
CHEMEX INDUSTRIAL CO., LTD.	Taiwan	–	registered
CHROMAGAR	France	–	registered
Cancer Diagnostics, Inc.	United States	–	registered
DiaTrust Medical Co., Ltd. Present in Europe in other categories	China	–	registered
Diapath S.p.A. Present in Europe in other categories	Italy	–	registered
Epredia Holdings Ltd.	United States	–	registered
General Data Company, Inc.	United States	–	registered
Guangzhou Labsim Biotech Co., Ltd Present in Europe in other categories	China	–	registered
Hangzhou Rollmed Co.,Ltd.	China	–	registered
Himedia Laboratories Private Limited	India	–	registered
Hive International Pvt Ltd.	Pakistan	–	registered
JIAOYUE PHARMACEUTICAL (HUIZHOU) CO.LTD	China	–	registered
Jiangsu Huida Medical Instruments Co., Ltd.	China	–	registered
KEY SCIENTIFIC PRODUCTS	United States	–	registered
Legacy Biologicals	United States	–	registered
Leica Biosystems, division of Leica Microsystems, Inc.	United States	–	registered
Les Plastiques MDJ inc.	Canada	–	registered
Life Technologies Corporation	United States	–	registered
MEDICAL CHEMICAL CORPORATION	United States	–	registered
MEDITE Medical GmbH Present in Europe in other categories	Germany	–	registered
Merck Life Science KGaA	Germany	–	registered
NORTH COAST MEDICAL, INC. Present in Europe in other categories	United States	–	registered
Polysciences, Inc.	United States	–	registered
Poth Hille & Co Ltd Present in Europe in other categories	United Kingdom	–	registered
READY SET IMPORT dba Mynt Professional	United States	–	registered
SIAM INTERMAGNATE CO., LTD. Present in Europe in other categories	Thailand	–	registered
SIDMAN INDUSTRIES	India	–	registered
SIMPORT SCIENTIFIC INC.	Canada	–	registered
SLMP LLC (STATLAB MEDICAL PRODUCTS) Present in Europe in other categories	United States	–	registered
Sakura Global Holding Company	United States	–	registered
Sanicure BV	Netherlands	–	registered
SunMed Group Holdings, LLC dba AirLife	United States	–	registered
TRAJAN SCIENTIFIC AUSTRALIA PTY LTD Present in Europe in other categories	Australia	–	registered
UNI MEDITREK PRIVATE LIMITED	India	–	registered
Yancheng Jingwei Chemicals Co., Ltd	China	–	registered

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