Identity
- Trade Name
- HEKA EUDAMED
- Device Name
- First Aid Bandage EUDAMED
- Model / Reference
- VA0810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975662250114 EUDAMED
- Basic UDI-DI
- 697566225BANDAGEDRESSIN6T EUDAMED
- Direct Marketing DI
- 06975662250114 EUDAMED
- EMDN Code
- M0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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 by Suzhou Vicon Industrial CO., LTD. — 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 | 697566225BANDAGEDRESSIN6T | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Vicon Industrial CO., LTD.
- EUDAMED SRN
- CN-MF-000028246
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e3fe37eb-e418-4c47-8c78-c9bdfced3629 61 fields · synced Jun 19, 2026