Identity
- Trade Name
- Histanol EP 9010, 5000 mL EUDAMED
- Device Name
- Reagensi za procesiranje i pomoćni reagensi za histologiju/citologiju EUDAMED
- Model / Reference
- HEP91-5L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892124673 EUDAMED
- Basic UDI-DI
- 385889212HPC30799PROCYU EUDAMED
- Direct Marketing DI
- 03858892124673 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER 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
Histanol EP 9010, 5000 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 | 385889212HPC30799PROCYU | Class A | Active |
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Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED d7a55308-a45b-42c3-bcfb-8ede1d4c8355 61 fields · synced Jun 18, 2026