Identity
- Trade Name
- SpermMar Test IgA Complete kit EUDAMED
- Device Name
- SpermMar Test IgA Complete kit EUDAMED
- Model / Reference
- SPMA_C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05411967001347 EUDAMED
- Basic UDI-DI
- 5411967SPMAC1YL EUDAMED
- Direct Marketing DI
- 05411967001347 EUDAMED
- EMDN Code
- W0102109013 SPERM ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
SpermMar Test IgA Complete kit by FertiPro — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5411967SPMAC1YL | Class B | Active |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (1)
- EUDAMED 97464dc4-bfb2-4bfb-aeca-93520deee95c 61 fields · synced Jun 18, 2026