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Haiim Vacuum-assisted blood collection system Main Device Plus

by Winnoz Technology, Inc. EUDAMED

Active European Union

Ref HD-101Model WH-003

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471988964WH-003LU Basic UDI-DIDate19 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Haiim Vacuum-assisted blood collection system Plus
Model / Reference
WH-003, HD-101
Primary DI / UDI-DI
04719889640196
Basic UDI-DI
471988964WH-003LU
Direct Marketing DI
04719889640196
EMDN Code
W0501010201 Capillary blood collection systems
Device Class
Class A
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