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Heka

by Allion BV h.o.d.n. van Heek Medical Netherlands EUDAMED

Ref TR0099-1

EMDN M9099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8715886VerbandkofferPT Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Heka First Aid
Model / Reference
TR0099-1
Primary DI / UDI-DI
08715886030080
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 & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 08dcbd96-5a7a-478c-a2fa-a24fe6a0021b 61 fields · synced 24 Oct 2026