Identity
- Trade Name
- GeneProof PathogenFree DNA Isolation Kit EUDAMED
- Device Name
- GeneProof PathogenFree DNA Isolation Kit EUDAMED
- Model / Reference
- IDNA050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594161959502 EUDAMED
- Basic UDI-DI
- 859569630048QV EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
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 PathogenFree DNA Isolation Kit by GeneProof a.s. — Class A — 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 | 859569630048QV | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (2)
- EUDAMED 0843ad97-9ca8-4b2a-8845-08a72a320edc 61 fields · synced Jul 10, 2026
- EUDAMED ae69a5d7-6923-4249-b38e-9efff3a8c0cf 61 fields · synced Jul 10, 2026