Identity
- Trade Name
- BioFix HD, 500 mL EUDAMED
- Device Name
- Fiksativi EUDAMED
- Model / Reference
- BFHD-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858890003536 EUDAMED
- Basic UDI-DI
- 385889212HPC30705FIXAQX EUDAMED
- Direct Marketing DI
- 03858890003536 EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) 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
BioFix HD, 500 mL 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 | 385889212HPC30705FIXAQX | Class A | Active |
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Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED b655552e-79fa-4e92-ac38-1437b4e345f9 61 fields · synced Jun 18, 2026