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Hi-Swab DNA Kit

by Tiangen Biotech (Beijing) Co., Ltd. 2 variants

Ref CDP362-02Model CDP362-01, CDP362-02

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697548997CDP362TX Basic UDI-DI 06975489971117UDI-DIDate24 Aug 2022RegisteredStatusActive

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  • Withdrawn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
CDP362-01, CDP362-02
Primary DI / UDI-DI
06975489971117
Basic UDI-DI
697548997CDP362TX
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000026594
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Tiangen Biotech (Beijing) Co., Ltd.

See all devices from Tiangen Biotech (Beijing) Co., Ltd. →

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