Identity
- Trade Name
- EmbryoViewer EUDAMED
- Device Name
- EmbryoViewer version 7 (incl. Guided Annotation) EUDAMED
- Model / Reference
- 16622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712714676222 EUDAMED
- Basic UDI-DI
- 5712714SWA-01S4 EUDAMED
- Direct Marketing DI
- 05712714676222 EUDAMED
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software 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
EmbryoViewer by Vitrolife A/S — Class I — 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 | 5712714SWA-01S4 | Class I | Active |
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Manufacturer
- Manufacturer
- Vitrolife A/S
- EUDAMED SRN
- DK-MF-000001892
Sources (1)
- EUDAMED 1b10efa7-118a-4aef-8af1-bc2fca8d5919 61 fields · synced Jul 21, 2026