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DBS CoreShell-Dried Blood Spot Kit

by Sinopharm Allmed (Hubei) Medical Products Co., Ltd.

Model 60 uL

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697421006DBS0015F Basic UDI-DI Date8 Jun 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
60 uL
Primary DI / UDI-DI
06974210060021, 06974210060014
Basic UDI-DI
697421006DBS0015F
EMDN Code
W0501010299 Capillary blood collection devices - other
Device Class
Class A
EU market of registration
Germany
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000011464
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • New Device YesEUDAMEDNoEUDAMED

Other properties (10)

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