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Haiim Vacuum-assisted blood collection system Cassette-X (Non-sterile)

by Winnoz Technology, Inc.

Ref HC-004Model WH-003

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 Number471988964WH-003LU Basic UDI-DI 04719889640226UDI-DIDate19 Aug 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  • Withdrawn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

Device Name
Haiim Vacuum-assisted blood collection system Plus
Model / Reference
WH-003, HC-004
Primary DI / UDI-DI
04719889640226
Basic UDI-DI
471988964WH-003LU
Unit of Use DI
04719889640219
EMDN Code
W0501010201 Capillary blood collection systems
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000036356
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No