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Hem-Col

by Labonovum B.V. 4 variants

Ref 8719324619004Model Hem-Col EDTA

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 Number11522518719324619004A2 Basic UDI-DI 08719324619004UDI-DIDate3 Oct 2023RegisteredStatusActive

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  • Withdrawn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
Hem-Col EDTA
Model / Reference
Hem-Col EDTA, 8719324619004
Primary DI / UDI-DI
08719324619004
Basic UDI-DI
11522518719324619004A2
Direct Marketing DI
08719324619004
EMDN Code
W0501010203 Blood collection, capillary tubes
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000023312

Other devices from Labonovum B.V.

Properties

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No