IVD instrumentsGeneral purpose IVD instrumentsBiological hoods and cabinets
Chemical filtration air closets
EMDN code W02070304
Manufacturers registered in Europe (EUDAMED) 6
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 20
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 |
|---|---|---|---|
| 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) |
| Hua Yue Medical Technology Co., Ltd. | China | Harioculture TL-16 Time-lapse Incubator Time-lapse Incubator Capacity Expansion Module | K242684 (2025) |
| 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) |
| Rocket Medical Plc Present in Europe in other categories | United Kingdom | Rocket | K000394 (2000) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | – | registered |
| At Medical Uab | Lithuania | – | K151357 (2016) |
| Cook, Inc. | United States | – | registered |
| PLEXUS CORP. | United States | – | registered |
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | China | – | 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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