N-Histofine Simple Stain MAX PO (R)

by Nichirei Biosciences Inc. 4 variants

Ref 414142F

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number4987780detectionAWT Basic UDI-DI 04987780879636UDI-DI	Date25 May 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: N-Histofine Simple Stain MAX PO
Model / Reference: 414142F

Primary DI / UDI-DI: 04987780879636
Basic UDI-DI: 4987780detectionAWT
Direct Marketing DI: 04987780879636
EMDN Code: W01030710 Secondary antisera for immunohistology

Device Class: Class A
EU market of registration: Czechia

Manufacturer details

EUDAMED SRN: JP-MF-000027151
Authorised representative: MedEnvoy Global BV NL-AR-000024028

Other devices from Nichirei Biosciences Inc.

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N-Histofine Simple Stain MAX PO (MULTI)

Class A
N-Histofine Simple Stain MAX PO (M)

Class A
N-Histofine Simple Stain AEC Solution

Class A
N-Histofine DAB-3S KIT

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See all devices from Nichirei Biosciences Inc. →

Properties

Reagent
Professional Testing

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No