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Reaction Cup

by Xiamen Innodx Biotech Co., Ltd. 4 variants

Ref PRC-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 Number69736007900909S Basic UDI-DI 06973600799923UDI-DIDate10 Feb 2026RegisteredStatusActive

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  • Withdrawn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
PRC-02
Primary DI / UDI-DI
06973600799923
Basic UDI-DI
69736007900909S
EMDN Code
W0503010280 Samples analyses, plastic containers - other accessories
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000041071
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Xiamen Innodx Biotech Co., Ltd.

See all devices from Xiamen Innodx Biotech Co., Ltd. →

Properties

  • Professional Testing

Other properties (10)

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