Identity
- Trade Name
- BOUIN ROZTOK EUDAMED
- Device Name
- BOUIN ROZTOK EUDAMED
- Model / Reference
- 11020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595142260105 EUDAMED
- Basic UDI-DI
- 859514221102064 EUDAMED
- Direct Marketing DI
- 08595142260105 EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) 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
Bouin 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 | 859514221102064 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ing. Petr Švec - PENTA s.r.o.
- EUDAMED SRN
- CZ-MF-000035988
Sources (1)
- EUDAMED 591d0f6b-4d73-4133-b56d-da088dc78130 61 fields · synced Jul 13, 2026