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Heka

by Allion BV h.o.d.n. van Heek Medical 32 variants

Ref TR0066-2

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8715886VerbandkofferPT Basic UDI-DI 08715886030066UDI-DIDate4 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Heka First Aid
Model / Reference
TR0066-2
Primary DI / UDI-DI
08715886030066
Basic UDI-DI
8715886VerbandkofferPT
EMDN Code
M9099 General and specialist medical devices – other (suture patches see h900102)
Device Class
Class IIb
Medical Purpose
The First Aid Kit, supplied as a system / procedure pack, is intended for the immediate and temporary management of minor injuries. Its medical purpose is to enable basic first aid actions such as cleaning wounds, absorbing blood or exudate, covering and protecting minor cuts, abrasions, blisters, and superficial burns, and providing basic support or fixation. The system combines essential first aid components in an organised and accessible manner to support prompt initial response in non‑clinical environments.

Manufacturer details

EUDAMED SRN
NL-PR-000015343

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Properties

Other properties (1)

  • Sterile: No