Identity
- Trade Name
- Heka Dur Tex EUDAMED
- Device Name
- Heka Compression box EUDAMED
- Model / Reference
- WI1100-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886027288 EUDAMED
- Basic UDI-DI
- 8715886Compressiebox3G EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The HEKA compression box contains a complete package containing the main products for the treatment of patients with venous insufficiency who start ambulatory compression therapy. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Compression/pressure sock/stocking, reusable
Heka Dur Tex 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 Compression/pressure sock/stocking, reusable.
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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 | 8715886Compressiebox3G | Class I | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-PR-000015343
Sources (1)
- EUDAMED 9c97a762-183e-4d99-8fed-699d9a3a06bb 61 fields · synced Jun 18, 2026