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Heka Soft

by Allion BV h.o.d.n. van Heek Medical 9 variants

Ref NK0280

Active European Union

CE MDR

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/MDR Number8715886NonWovenKompresKM Basic UDI-DI 08715886006382UDI-DIDate8 Feb 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Non-woven swab
Model / Reference
NK0280
Primary DI / UDI-DI
08715886006382
Basic UDI-DI
8715886NonWovenKompresKM
EMDN Code
M0202010102 Non-woven folded gauzes, without x-ray detectable thread, non-sterile
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000003490

Other devices from Allion BV h.o.d.n. van Heek Medical

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No