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Specimen Container

by CompAI MedTech(Suzhou) Co. Ltd

Ref H000005

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 Number697497058SC6Y Basic UDI-DI 06974970580043UDI-DIDate3 Feb 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  • Withdrawn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

Device Name
Specimen Container
Model / Reference
H000005
Primary DI / UDI-DI
06974970580043
Basic UDI-DI
697497058SC6Y
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000020924
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from CompAI MedTech (Suzhou) Co., Ltd.

Properties

  • Surgical Instrument

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
  • New Device: No