Identity
- Trade Name
- GRAM II roztok EUDAMED
- Device Name
- GRAM II ROZTOK EUDAMED
- Model / Reference
- 14610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595142249803 EUDAMED
- Basic UDI-DI
- 85951422146107L EUDAMED
- Direct Marketing DI
- 08595142249803 EUDAMED
- EMDN Code
- W0104080203 GRAM POSITIVE - MANUAL IDENTIFICATION 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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
GRAM II roztok by Ing. Petr Švec - PENTA s.r.o. — 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 | 85951422146107L | Class A | Active |
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Manufacturer
- Manufacturer
- Ing. Petr Švec - PENTA s.r.o.
- EUDAMED SRN
- CZ-MF-000035988
Sources (1)
- EUDAMED b2b00fe9-335e-4b3c-92f2-5bd187d7e1ca 61 fields · synced Jun 17, 2026