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Aerobic Culture Bottles

by Recovery (Hk) Technology Limited EUDAMED

Withdrawn No longer placed on the EU market

Ref CSY-01001Model Standard Aerobic Bottle for adult(Chromogenic Detection Method)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04897147600028 Basic UDI-DIDate27 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Aerobic Culture Bottle
Model / Reference
Standard Aerobic Bottle for adult(Chromogenic Detection Method), CSY-01001
Primary DI / UDI-DI
04897147600028
Basic UDI-DI
B-04897147600028
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

  • Sterile
  • Professional Testing
  • Companion Diagnostics

Other properties (7)

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