Identity
- Trade Name
- EmbryoScope Flex EUDAMED
- Device Name
- EmbryoScope+ EUDAMED
- Model / Reference
- 16405 EUDAMED16406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712714604058 EUDAMED05712714604065 EUDAMED
- Basic UDI-DI
- 5712714INC-01KD EUDAMED
- Direct Marketing DI
- 05712714604058 EUDAMED05712714604065 EUDAMED
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Category: Assisted reproduction vitrification carrier
EmbryoScope Flex by Vitrolife A/S — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5712714INC-01KD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vitrolife A/S
- EUDAMED SRN
- DK-MF-000001892
Sources (2)
- EUDAMED df1ec9d6-a329-4b87-9696-eda25238c64a 61 fields · synced Jul 10, 2026
- EUDAMED 321b9e96-1c89-4aec-b4aa-81efbed42191 61 fields · synced May 18, 2026