Identity
- Trade Name
- EmbryoSlide Flex culture dish EUDAMED
- Device Name
- EmbryoSlide+ EUDAMED
- Model / Reference
- 16453 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712714664533 EUDAMED
- Basic UDI-DI
- 5712714DISH-01M2 EUDAMED
- EMDN Code
- U080206 CULTURE PLATES FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EmbryoSlide Flex culture dish by Vitrolife A/S — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150961 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5712714DISH-01M2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vitrolife A/S
- EUDAMED SRN
- DK-MF-000001892
Sources (2)
- EUDAMED 5b7fb088-d8dd-4d36-b94f-0f1ac88215c0 61 fields · synced Jul 10, 2026
- FDA 510(k) K150961 1 fields · synced May 18, 2026