Identity
- Trade Name
- Heka Soft EUDAMED
- Device Name
- Non-woven swab EUDAMED
- Model / Reference
- NK0450 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886015438 EUDAMED
- Basic UDI-DI
- 8715886NonWovenKompresKM EUDAMED
- Unit of Use DI
- 08715886015421 EUDAMED
- EMDN Code
- M0202010102 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE 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
Heka Soft 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 | 8715886NonWovenKompresKM | 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 efbca269-7c5f-4aa1-acdb-bb2017717a51 61 fields · synced Jun 19, 2026