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One Step Polymer HRP, for 1250 tests, 125 mL

EUDAMED

Class A (EU MDR)

Ref IHC-1HRP-R125

by BioGnost Ltd.

Identity

Trade Name
One Step Polymer HRP, for 1250 tests, 125 mL EUDAMED
Device Name
Popratni reagensi za imunohistokemijsko bojenje EUDAMED
Model / Reference
IHC-1HRP-R125 EUDAMED

Identifiers

Primary DI / UDI-DI
03858892125465 EUDAMED
Basic UDI-DI
385889212HPC30711AIHCMH EUDAMED
Direct Marketing DI
03858892125465 EUDAMED
EMDN Code
W01030711 IMMUNOHISTOLOGY KITS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Croatia 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

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

One Step Polymer HRP, for 1250 tests, 125 mL by BioGnost Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.

Manufacturer's product page: For Professional Use

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
BioGnost Ltd.
EUDAMED SRN
HR-MF-000022153

Sources (1)

  • EUDAMED 1328a068-6f93-4841-91e9-4112f47d2451 61 fields · synced Jul 9, 2026