Identity
- Trade Name
- Mikrotitrační destička U EUDAMED
- Device Name
- Mikrotitrační destičky EUDAMED
- Model / Reference
- V400916 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540400345 EUDAMED
- Basic UDI-DI
- 85935409MTDUAP42 EUDAMED
- Unit of Use DI
- 08593540400352 EUDAMED
- EMDN Code
- W0503010204 SAMPLES ANALYSES, PLASTIC DISHES FOR MICROTECHNIQUES 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Mikrotitrační destička U by GAMA GROUP 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 | 85935409MTDUAP42 | Class A | Active |
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Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED f3821108-7329-4afa-b82d-222f1d4c188f 61 fields · synced Jun 17, 2026