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Universal, HRP Polymer Detection System 1 Kit(s)

EUDAMED

Class A (EU MDR)

Ref UPK999

by ScyTek Laboratories Inc.

Identity

Trade Name
Universal, HRP Polymer Detection System 1 Kit(s) EUDAMED
Device Name
Immunohistology Kits EUDAMED
Model / Reference
UPK999 EUDAMED

Identifiers

Primary DI / UDI-DI
00810108719472 EUDAMED
Basic UDI-DI
081010871W01030711F5 EUDAMED
Direct Marketing DI
00810108719472 EUDAMED
EMDN Code
W01030711 IMMUNOHISTOLOGY KITS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Netherlands 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

Universal, HRP Polymer Detection System 1 Kit(s) by ScyTek Laboratories Inc. — 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
ScyTek Laboratories Inc.
EUDAMED SRN
US-MF-000023816
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED d60aec35-f60c-449a-a27c-859061e0796e 61 fields · synced Jun 18, 2026