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Specimen Radiography System

by CompAI MedTech(Suzhou) Co. Ltd 2 variants

Ref H000042

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 Number697497058SRS2D Basic UDI-DI 06974970580067UDI-DIDate31 Jan 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  • Withdrawn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 Radiography System
Model / Reference
H000042
Primary DI / UDI-DI
06974970580067
Basic UDI-DI
697497058SRS2D
Direct Marketing DI
06974970580067
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