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Anouve

by Qingdao Anouve Biological Medical Technology Co., Ltd. 5 variants

Ref P03CR01-01Model 5 mL tube, 50 tubes/box

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697597808CRGZA Basic UDI-DI 06975978080023UDI-DIDate14 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Device Name
Cell-Free RNA Storage Tube (Glass)
Model / Reference
5 mL tube, 50 tubes/box, P03CR01-01
Primary DI / UDI-DI
06975978080023
Basic UDI-DI
697597808CRGZA
Direct Marketing DI
06975978080023
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000048990
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

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