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D-Dimer Rapid Test Device (Colloidal Gold)

by Hangzhou Realy Tech Co., Ltd. 2 variants

Ref B010216D

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-06971792054028 Basic UDI-DI 06971792054028UDI-DIDate18 May 2023RegisteredStatusActive

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  • Withdrawn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
B010216D
Primary DI / UDI-DI
06971792054028
Basic UDI-DI
B-06971792054028
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000004716
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hangzhou Realy Tech Co., Ltd.

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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