Identity
- Trade Name
- Hekura urifix EUDAMED
- Device Name
- Catheter Fixation EUDAMED
- Model / Reference
- UZ8860 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886024010 EUDAMED
- Basic UDI-DI
- 8715886KatheterFixatie43 EUDAMED
- EMDN Code
- U0180,U0280 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
Hekura urifix 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 | 8715886KatheterFixatie43 | 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 4c3fb1af-aeb7-499d-961c-3d0529b98170 61 fields · synced Oct 6, 2026