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Synaptophysin Antibody Reagent (Immunohistochemistry)

by Shenzhen Dartmon Biotechnology Co., Ltd.

Ref RMA1A030

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06927210902853 Basic UDI-DI Date24 Jun 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
RMA1A030
Primary DI / UDI-DI
06927210902853, 06927210902914, 06927210902891, 06927210902877, 06927210902846, 06927210902860, 06927210902839, 06927210902907, 06927210902921, 06927210902884, 06975503520307
Basic UDI-DI
B-06927210902853, B-06927210902914, B-06927210902891, B-06927210902877, B-06927210902846, B-06927210902860, B-06927210902839, B-06927210902907, B-06927210902921, B-06927210902884, B-06975503520307
EMDN Code
W01030709 Primary antisera for immunohistology
Device Class
Class IVD General
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000019183
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Shenzhen Dartmon Biotechnology Co., Ltd.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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