Identity
- Trade Name
- EmbryoSlide+ ic8 dish EUDAMED
- Device Name
- EmbryoSlide+ EUDAMED
- Model / Reference
- 16454 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712714664540 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+ ic8 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 | K213869 | 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 db342840-fc60-4eb3-b966-2931aa2f84a1 61 fields · synced Jun 20, 2026
- FDA 510(k) K213869 1 fields · synced May 18, 2026