Identity
- Trade Name
- SpermFreeze Box EUDAMED
- Device Name
- SpermFreeze Box EUDAMED
- Model / Reference
- SPF_BOX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05411967004911 EUDAMED
- Basic UDI-DI
- 5411967SPFBOX15C EUDAMED
- Direct Marketing DI
- 05411967004911 EUDAMED
- EMDN Code
- U08020599 SUBSTRATES FOR STORING/HANDLING BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
SpermFreeze Box by FertiPro — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5411967SPFBOX15C | Class I | Active |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (1)
- EUDAMED 4f8249cd-8031-4fa5-b249-baa186d508c5 61 fields · synced Jul 14, 2026