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Cyclin D1 Antibody (Immunohistochemistry)

by Xiamen Talent Biomedical Technology Co., Ltd

Ref 0.2ml, 11ml, 3ml, 1ml, 6ml

Active European Union

CE IVDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06937455435832 Basic UDI-DI Date6 Jun 2025RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Cyclin D1 Antibody (Immunohistochemistry)
Model / Reference
0.2ml, 11ml, 3ml, 1ml, 6ml
Primary DI / UDI-DI
06937455435832, 06937455435870, 06937455435856, 06937455435849, 06937455435863, 06937455440614
Basic UDI-DI
B-06937455435832, B-06937455435870, B-06937455435856, B-06937455435849, B-06937455435863, B-06937455440614
EMDN Code
W01030709 Primary antisera for immunohistology
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039397
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No