Identity
- Trade Name
- GeneProof Universal Internal Control EUDAMED
- Device Name
- GeneProof Universal Internal Control EUDAMED
- Model / Reference
- UNIC/GP/010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696305086 EUDAMED
- Basic UDI-DI
- 859569630004Q9 EUDAMED
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
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
GeneProof Universal Internal Control by GeneProof a.s. — 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 | 859569630004Q9 | Class B | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (2)
- EUDAMED cf760025-9608-4219-a4a8-ffaad7e2854e 61 fields · synced Jun 18, 2026
- EUDAMED ef677804-8415-41ce-b963-5d3a5d4fb72b 61 fields · synced Jun 18, 2026