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Permanent Red Chromogen Kit

by Cell Marque Corporation 2 variants

Ref 960D-10Model 960D-X series

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number008416831960DUK Basic UDI-DI 00841683101895UDI-DIDate17 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
960D-X series, 960D-10
Primary DI / UDI-DI
00841683101895
Basic UDI-DI
008416831960DUK
EMDN Code
W01030711 Immunohistology kits
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000028332
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Other devices from Cell Marque Corporation

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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