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Heka Soft
EUDAMEDClass I (EU MDR)
Ref NK0580Ref NK0540Ref NK0280Ref NK0510Ref NK0250
Identity
- Trade Name
- Heka Soft EUDAMED
- Device Name
- Non-woven swab EUDAMED
- Model / Reference
- NK0580 EUDAMEDNK0540 EUDAMEDNK0280 EUDAMEDNK0510 EUDAMEDNK0250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886008386 EUDAMED08715886006047 EUDAMED08715886006382 EUDAMED08715886000458 EUDAMED08715886000434 EUDAMED
- Basic UDI-DI
- 8715886NonWovenKompresKM EUDAMED
- EMDN Code
- M0202010102 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE 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
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 (5)
- EUDAMED 2d4aa543-86ac-4c6f-954e-f60c3b71d2ea 61 fields · synced Oct 6, 2026
- EUDAMED 399b2d6e-626b-4e2d-8318-9901d8f5a7ee 61 fields · synced May 17, 2026
- EUDAMED 6311457d-3d8b-42b6-b176-9d860c3b0ccd 61 fields · synced May 17, 2026
- EUDAMED fa44d780-5f96-45b8-b6d5-66d0eb53440e 61 fields · synced May 18, 2026
- EUDAMED cad9ae0f-163a-4fde-9b35-7fea1d4ef7bc 61 fields · synced May 18, 2026