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Automated Blood Culture System

by Recovery (Hk) Technology Limited

Ref ABC-40,ABC-60,ABC-120,ABC-240,ABC-480

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number489714760RECOVERY0001MV Basic UDI-DI 04897147600011UDI-DIDate24 May 2026RegisteredStatusActive EUDAMED: not 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
ABC-40, ABC-60, ABC-120, ABC-240, ABC-480
Primary DI / UDI-DI
04897147600011
Basic UDI-DI
489714760RECOVERY0001MV
Direct Marketing DI
04897147600011
EMDN Code
W02030201 Automated blood culture analysers
Device Class
Class A
Special Device Type
Software

Manufacturer details

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

Properties

  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
  • New Device

Other properties (7)

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