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Heka

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

Ref TR0011-2

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 linked in EUDAMED

A group certificate may exist

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 Number8715886VerbandkofferPT Basic UDI-DI 08715886027301UDI-DIDate4 May 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Heka First Aid
Model / Reference
TR0011-2
Primary DI / UDI-DI
08715886027301
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