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Anaerobic Blood Culture Bottles

by Recovery (Hk) Technology Limited

Ref CSY-02001Model Standard Anaerobic bottles for adult(Chromogenic Detection Method)

Withdrawn Withdrawn in European Union.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

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04897147600035 Basic UDI-DI 04897147600035UDI-DIDate27 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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
Anaerobic Culture Bottle
Model / Reference
Standard Anaerobic bottles for adult(Chromogenic Detection Method), CSY-02001
Primary DI / UDI-DI
04897147600035
Basic UDI-DI
B-04897147600035
EMDN Code
W0104010504 Bottles for automated blood culture
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
HK-MF-000048304
Authorised representative
Medunion S.L. ES-AR-000019366

Properties

  • Professional Testing
  • Companion Diagnostics

Other properties (8)

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