← Back to catalogue
N-Histofine Simple Stain MAX PO (M)
EUDAMEDClass A (EU MDR)
Ref 414131FRef 414132FRef 434131F
Identity
- Trade Name
- N-Histofine Simple Stain MAX PO (M) EUDAMED
- Device Name
- N-Histofine Simple Stain MAX PO EUDAMED
- Model / Reference
- 414131F EUDAMED414132F EUDAMED434131F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987780879551 EUDAMED04987780879575 EUDAMED04987780861037 EUDAMED
- Basic UDI-DI
- 4987780detectionAWT EUDAMED
- Direct Marketing DI
- 04987780879551 EUDAMED04987780879575 EUDAMED04987780861037 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nichirei Biosciences Inc.
- EUDAMED SRN
- JP-MF-000027151
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED aa03cdf2-4e4c-45dc-9b09-d77b8db35744 61 fields · synced Jul 17, 2026
- EUDAMED d6667c47-c38d-4910-aa7f-0d3a55dacc5c 61 fields · synced May 19, 2026
- EUDAMED 96281a04-001d-4bc0-bf00-5ab76bd8dcbc 61 fields · synced May 19, 2026