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N-Histofine Simple Stain AEC Solution
EUDAMEDClass A (EU MDR)
Ref 415182FRef 435181F
Identity
- Trade Name
- N-Histofine Simple Stain AEC Solution EUDAMED
- Device Name
- N-Histofine EUDAMED
- Model / Reference
- 415182F EUDAMED435181F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987780860153 EUDAMED04987780861488 EUDAMED
- Basic UDI-DI
- 4987780ancillariesA4X EUDAMED
- Direct Marketing DI
- 04987780860153 EUDAMED04987780861488 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) 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 AEC Solution 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 | 4987780ancillariesA4X | 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 (2)
- EUDAMED 3ebddd6a-0b61-473f-b347-144340dc5b8b 61 fields · synced Jul 30, 2026
- EUDAMED 0f0a123c-1e72-43dd-9987-fac279d5f655 61 fields · synced May 18, 2026