Identity
- Trade Name
- Heka EUDAMED
- Device Name
- Film EUDAMED
- Model / Reference
- PL0054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886015186 EUDAMED
- Basic UDI-DI
- 8715886WondfolieEA EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Scar-management dressing, reusable
Heka by Allion BV h.o.d.n. van Heek Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- THERAFOAM — BIODERMIS LLC · Class I
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 | 8715886WondfolieEA | Class I | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-MF-000003490
Sources (1)
- EUDAMED 18793ec9-f983-4bb6-9462-47d2d8acc359 61 fields · synced Jun 17, 2026