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HiDef Detection Alk Phos Polymer System

EUDAMED

Class A (EU MDR)

Ref 962D-10Model 962D-X Series

by Cell Marque Corporation

Identity

Trade Name
HiDef Detection Alk Phos Polymer System EUDAMED
Device Name
HiDef Detection Alk Phos Polymer System EUDAMED
Model / Reference
962D-X Series EUDAMED
962D-10 EUDAMED

Identifiers

Primary DI / UDI-DI
00841683101932 EUDAMED
Basic UDI-DI
008416831962DUR EUDAMED
EMDN Code
W01030711 IMMUNOHISTOLOGY KITS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

HiDef Detection Alk Phos Polymer System by Cell Marque Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Cell Marque Corporation
EUDAMED SRN
US-MF-000028332
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 76452066-aae9-422c-bb87-4025c5ef80b7 61 fields · synced Aug 4, 2026