Identity
- Trade Name
- Heka Dur 2 EUDAMEDHeka Dur 2 LITE EUDAMED
- Device Name
- Bandages EUDAMED
- Model / Reference
- WI1200 EUDAMEDWI1201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886029947 EUDAMED08715886029961 EUDAMED
- Basic UDI-DI
- 8715886WindselsDF EUDAMED
- EMDN Code
- M0304010203 ELASTIC COMPRESSION BANDAGES, COHESIVE, HIGH EXTENSIBILITY (>140%) 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 Dur 2 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 (2)
- EUDAMED 912e789f-f46e-4570-8d80-fe470c259086 61 fields · synced Oct 6, 2026
- EUDAMED 38040c6e-a0fa-4818-8da1-c4558f893fa4 61 fields · synced May 18, 2026