Identity
- Trade Name
- Heka Cotton EUDAMED
- Device Name
- Cotton Balls EUDAMEDCotton Wool EUDAMED
- Model / Reference
- WA2510 EUDAMEDWA0003 EUDAMEDWA0001 EUDAMEDWA0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886021620 EUDAMED08715886005651 EUDAMED08715886005590 EUDAMED08715886005682 EUDAMED
- Basic UDI-DI
- 8715886WattenBolAB EUDAMED8715886Watten67 EUDAMED
- EMDN Code
- M010102 PURE COTTON 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 Cotton 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 | 8715886WattenBolAB | Class I | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-MF-000003490
Sources (4)
- EUDAMED c8cc483b-1fe5-411a-bfb3-bbc1262265e4 61 fields · synced Oct 6, 2026
- EUDAMED 453a0958-e6cc-494c-abe5-e85ed035d2a4 61 fields · synced May 17, 2026
- EUDAMED ce996ae0-a754-4995-994a-dd508b2cb5dc 61 fields · synced May 18, 2026
- EUDAMED fcb2d50b-d099-46ed-ab74-dba83e93a4c2 61 fields · synced May 19, 2026