Identity
- Trade Name
- CulturePro EUDAMED
- Device Name
- CulturePro EUDAMED
- Model / Reference
- 16305 EUDAMED16306 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712714703058 EUDAMED05712714703065 EUDAMED
- Basic UDI-DI
- 5712714INC-03KH EUDAMED
- Direct Marketing DI
- 05712714703058 EUDAMED05712714703065 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
CulturePro 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-03KH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vitrolife A/S
- EUDAMED SRN
- DK-MF-000001892
Sources (2)
- EUDAMED 5ed6512b-33a0-47f5-94c5-ba993deec39d 61 fields · synced Jul 14, 2026
- EUDAMED 77352030-c74f-4f95-9b40-4cca48bbe39d 61 fields · synced May 18, 2026