← Back to catalogue

Two Step HRP Detection System, for 100 tests

EUDAMED

Class A (EU MDR)

Ref IHC-2DSHRP-T100

by BioGnost Ltd.

Identity

Trade Name
Two Step HRP Detection System, for 100 tests EUDAMED
Device Name
Popratni reagensi za imunohistokemijsko bojenje EUDAMED
Model / Reference
IHC-2DSHRP-T100 EUDAMED

Identifiers

Primary DI / UDI-DI
03858892125526 EUDAMED
Basic UDI-DI
385889212HPC30711AIHCMH EUDAMED
Direct Marketing DI
03858892125526 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

Two Step HRP Detection System, for 100 tests 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
BioGnost Ltd.
EUDAMED SRN
HR-MF-000022153

Sources (1)

  • EUDAMED 0bd38d47-66db-4986-89a6-b08fecae1d9c 61 fields · synced Jul 13, 2026