Identity
- Trade Name
- Hekura EUDAMED
- Device Name
- Hekura Set EUDAMED
- Model / Reference
- UZ9900-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886015698 EUDAMED
- Basic UDI-DI
- 8715886UrineafvoerSetGC EUDAMED
- EMDN Code
- T0499 INCONTINENCE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The Hekura urinary management sets are intended to support the safe, hygienic, and effective management of urinary drainage in adult patients requiring catheter‑based bladder emptying. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Hekura by Allion BV h.o.d.n. van Heek Medical — Class IIb — 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 | 8715886UrineafvoerSetGC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-PR-000015343
Sources (1)
- EUDAMED a740bdee-f16b-4dc5-af70-f90168520047 61 fields · synced Jun 18, 2026