Identity
- Trade Name
- Heka Cotton EUDAMED
- Device Name
- Cotton Balls EUDAMED
- Model / Reference
- WA2020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886021675 EUDAMED
- Basic UDI-DI
- 8715886WattenBolAB 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 (1)
- EUDAMED ac3d0f1b-1838-4e0b-ae93-c2cebadd9fcf 61 fields · synced Jun 19, 2026