Identity
- Trade Name
- Self cohesive bandage EUDAMED
- Device Name
- Cohesive Bandage EUDAMED
- Model / Reference
- HNCB0502 EUDAMEDHCSAB10O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973454363127 EUDAMED
- Basic UDI-DI
- 697345436HNCB0502WR EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Self cohesive bandage by Shanghai Hua En 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 | 697345436HNCB0502WR | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Hua En Industrial Co Ltd
- EUDAMED SRN
- CN-MF-000008902
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9deb2895-cec4-4ac2-a34d-8f774061632b 61 fields · synced Jun 18, 2026