Identity
- Trade Name
- Field kit, 2x1 L EUDAMED
- Device Name
- Reagensi za hematologiju EUDAMED
- Model / Reference
- FD-K-1L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892122198 EUDAMED
- Basic UDI-DI
- 385889212HPC3010302HMCA EUDAMED
- Direct Marketing DI
- 03858892122198 EUDAMED
- EMDN Code
- W0103010302 ROMANOWSKY STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia 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
Field kit, 2x1 L by BioGnost Ltd. — 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 | 385889212HPC3010302HMCA | Class A | Active |
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Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED 1a231639-633f-4f6d-8ce4-2e4a5c535b54 61 fields · synced Jun 17, 2026