Identity
- Trade Name
- HURO PATH® Filter (FNA) EUDAMED
- Device Name
- Slide Sample Processor EUDAMED
- Model / Reference
- AFFNA001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800038500426 EUDAMED
- Basic UDI-DI
- 88000385CZFILM2 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
HURO PATH® Filter (FNA) by CelltraZone Co., 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 | 88000385CZFILM2 | Class A | Active |
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Manufacturer
- Manufacturer
- CelltraZone Co., Ltd
- EUDAMED SRN
- KR-MF-000026492
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 41822107-f8cd-4269-9044-43fab80c4912 61 fields · synced Jul 9, 2026