Identity
- Trade Name
- Heka EUDAMED
- Device Name
- Heka First Aid EUDAMED
- Model / Reference
- TR0322-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886027066 EUDAMED
- Basic UDI-DI
- 8715886VerbandkofferPT EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- 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. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Heka by Allion BV h.o.d.n. van Heek Medical — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8715886VerbandkofferPT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-PR-000015343
Sources (1)
- EUDAMED cf715ea0-649d-410c-9fac-836b11b4b52e 61 fields · synced Jun 18, 2026