Identity
- Trade Name
- croGENE Real-Time PCR System EUDAMED
- Device Name
- croGENE Real-Time PCR System EUDAMED
- Model / Reference
- CGRT6/96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696305772 EUDAMED
- Basic UDI-DI
- 859569630077R4 EUDAMED
- Direct Marketing DI
- 08595696305772 EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
croGENE Real-Time PCR System 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 | 859569630077R4 | Class A | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (2)
- EUDAMED adb62011-6eaf-4264-80cc-9a3fbad44e91 61 fields · synced Jul 24, 2026
- EUDAMED 665420bf-82d3-4650-b446-409e97767bbd 61 fields · synced Jul 24, 2026