Heka
by Allion BV h.o.d.n. van Heek Medical 32 variants
Ref OT0088
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8715886VerbandkofferPT 08715886018576 | Date4 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Heka First Aid
- Model / Reference
- OT0088
- Primary DI / UDI-DI
- 08715886018576
- 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
Other devices from Allion BV h.o.d.n. van Heek Medical
Properties
Other properties (1)
- Sterile: No