IVD instruments
General purpose IVD instruments
EMDN code W0207
Manufacturers registered in Europe (EUDAMED) 55
- 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.
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) 40
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 |
|---|---|---|---|
| Nova Biomedical Corp. | United States | STAT PROFILE | registered |
| Instrumentation Laboratory CO Present in Europe in other categories | United States | GEM Premier 5000 PAK BG/COOX/TBILI 75 TEST GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TEST GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TEST GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST GEM Premier 5000 PAK BG/ISE/COOX 600 TEST | K980646 (1998) |
| THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC Present in Europe in other categories | – | Thermo Scientific Forma | registered |
| CRYO BIO SYSTEM | United States | STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15 STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND GREEN FLEXIBLE ROD / BLISTER 5X15 CBS STERILE HIGH SECURITY TUBE BY 50 UNITS STERILE CBS 0.5 ML STRAW FOR SPERM WITH YELLOW COTTON PLUG / 5 X 20 STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20 STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15 | K002595 (2000) |
| Planer Plc | United States | BT37 Incubator Kryo 360 Freezer Kryo 560 Freezer | K121566 (2012) |
| William A. Cook Australia Pty. , Ltd. Present in Europe in other categories | Australia | Cook | K160753 (2017) |
| ESCO MEDICAL TECHNOLOGIES UAB Present in Europe in other categories | Lithuania | Multiroom IVF incubator MIRI Time-Lapse Incubator Dish for MIRI TL | registered |
| Genea Biomedx Pty, Ltd. | Australia | Geri Connect Server (including software) Geri Embryo Incubator Geri Software Connect and Assess 2.0 Geri Software Connect and Assess 1.3 | K180188 (2018) |
| RESEARCH INSTRUMENTS LIMITED | United Kingdom | RI Witness CODA | K160504 (2016) |
| Vitrolife A/S Present in Europe in other categories | Denmark | EmbryoViewer EmbryoScope+ ES server EmbryoScope time-lapse incubator | K173264 (2018) |
| Wuhan Huchuang Union Technology Co., Ltd. Present in Europe in other categories | China | Metiec | K232493 (2024) |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | Drager Jaundice Meter, model JM-105 Drager Jaundice Meter, model JM-103 | K133175 (2014) |
| Hua Yue Medical Technology Co., Ltd. | China | Harioculture TL-16 Time-lapse Incubator Time-lapse Incubator Capacity Expansion Module | K242684 (2025) |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents RAPIDPoint® 500e Blood Gas System | K110277 (2011) |
| Thermo Electron LED GmbH | – | Thermo Scientific | registered |
| Coopersurgical, Inc. Present in Europe in other categories | United States | Wallace SurePro Embryo Replacement Catheter w/ Stylet | K261083 (2026) |
| REICHERT, INC. Present in Europe in other categories | United States | UNISTAT® Bilirubinometer Specimen Cuvettes | registered |
| Rocket Medical Plc Present in Europe in other categories | United Kingdom | Rocket | K000394 (2000) |
| AD Supply Group Limited | United Kingdom | – | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | – | registered |
| At Medical Uab | Lithuania | – | K151357 (2016) |
| Bionostics, Inc. | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| Cook, Inc. | United States | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Draegerwerk AG & CO Kgaa | Germany | – | registered |
| IVUS ILAC SANAYI VE TICARET AS | Türkiye | – | registered |
| Katecho, Inc. | United States | – | registered |
| Konica Minolta, Inc. Present in Europe in other categories | Japan | – | registered |
| PLEXUS CORP. | United States | – | registered |
| Platinum Focus Group Ltd. | United Kingdom | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | China | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Sebia Present in Europe in other categories | United States | – | registered |
| Sekisui Diagnostics, LLC Present in Europe in other categories | United States | – | registered |
| Sheng Sheng Yi (Beijing) Technology Company Limited | China | – | K260194 (2026) |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
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