Identity
- Trade Name
- Hekura Comfort EUDAMED
- Device Name
- Urine bags EUDAMED
- Model / Reference
- UZ5555-1 EUDAMEDUZ5050-1 EUDAMEDUZ5030-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886024515 EUDAMED08715886008638 EUDAMED08715886008898 EUDAMED
- Basic UDI-DI
- 8715886UrinezakkenEG EUDAMED
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES EUDAMEDA06030301 URINE COLLECTION BAGS 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
Hekura Comfort 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 | 8715886UrinezakkenEG | 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 e6096368-22e7-4c14-a23a-9b6fdad3910e 61 fields · synced Oct 6, 2026
- EUDAMED edfb89a5-ecd6-4adc-a136-e0709ecc4001 61 fields · synced May 18, 2026
- EUDAMED a829556e-c18d-43d0-a661-c8d95ce22f2d 61 fields · synced May 19, 2026