Identity
- Trade Name
- N-Histofine Simple Stain MAX PO (M) EUDAMED
- Device Name
- N-Histofine Simple Stain MAX PO EUDAMED
- Model / Reference
- 414134F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987780879599 EUDAMED
- Basic UDI-DI
- 4987780detectionAWT EUDAMED
- Direct Marketing DI
- 04987780879599 EUDAMED
- EMDN Code
- W01030710 SECONDARY ANTISERA FOR IMMUNOHISTOLOGY 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
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
N-Histofine Simple Stain MAX PO (M) by Nichirei Biosciences Inc. — 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 | 4987780detectionAWT | Class A | Active |
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Manufacturer
- Manufacturer
- Nichirei Biosciences Inc.
- EUDAMED SRN
- JP-MF-000027151
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 5c5ff7e7-51ac-4796-9f2b-f7cf09e3f6fa 61 fields · synced Jun 19, 2026