Identity
- Trade Name
- Heka Hydrofiel EUDAMED
- Device Name
- Bandages EUDAMED
- Model / Reference
- WI0026 EUDAMEDWI0022 EUDAMEDWI0020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886001707 EUDAMED08715886001646 EUDAMED08715886001615 EUDAMED
- Basic UDI-DI
- 8715886WindselsDF EUDAMED
- Unit of Use DI
- 08715886001691 EUDAMED08715886001639 EUDAMED08715886001608 EUDAMED
- EMDN Code
- M030101 HYDROPHILIC GAUZE BANDAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Heka Hydrofiel by Allion BV h.o.d.n. van Heek Medical — Class I — 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 | 8715886WindselsDF | Class I | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-MF-000003490
Sources (3)
- EUDAMED b6714498-aed1-4a4a-9fab-7b14e2f069c3 61 fields · synced Oct 6, 2026
- EUDAMED 9bb77cf1-a68f-4339-a919-e78b25d7d1bf 61 fields · synced May 18, 2026
- EUDAMED 97a4ac00-a917-40d4-a317-a5c39622faa9 61 fields · synced May 18, 2026