Identity
- Trade Name
- HEKA TRIANGULAR BANDAGE EUDAMED
- Model / Reference
- I EUDAMEDHD0600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975662250015 EUDAMED
- Basic UDI-DI
- 697566225TRIANGULAR8P EUDAMED
- EMDN Code
- M030101 HYDROPHILIC GAUZE BANDAGES 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 Triangular Bandage 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 | 697566225TRIANGULAR8P | 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 a50aa9da-278b-4bf5-874d-f4426c37cb88 61 fields · synced Jun 18, 2026