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Self cohesive bandage
EUDAMEDClass I (EU MDR)
Ref HCSAB075WModel HNCB0502Ref HCSAB05BLURef HCSAB05BLKRef HCSAB075BLKRef HCSAB10BLKRef HCSAB05RED
Identity
- Trade Name
- Self cohesive bandage EUDAMED
- Device Name
- Cohesive Bandage EUDAMED
- Model / Reference
- HNCB0502 EUDAMEDHCSAB075W EUDAMEDHCSAB05BLU EUDAMEDHCSAB05BLK EUDAMEDHCSAB075BLK EUDAMEDHCSAB10BLK EUDAMEDHCSAB05RED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973454363103 EUDAMED06973454363035 EUDAMED06973454363028 EUDAMED06973454363080 EUDAMED06973454363134 EUDAMED06973454363059 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 (6)
- EUDAMED 2aed7a9b-0f4d-4216-9e4d-d1dd4f9429a8 61 fields · synced Jul 31, 2026
- EUDAMED 4145b7be-d91b-48da-906d-8ea6adff8e2b 61 fields · synced May 16, 2026
- EUDAMED 6f13ec0f-a7c0-4bee-ac2e-a33d2e62a29f 61 fields · synced May 17, 2026
- EUDAMED fc3d2bb6-86f4-4fe7-99a6-f56f6d3ddff5 61 fields · synced May 18, 2026
- EUDAMED 84a30d71-f927-46a8-83ae-f5d30dd9c34b 61 fields · synced May 18, 2026
- EUDAMED e8938465-d9c3-4a05-9b3c-dd74aa929c12 61 fields · synced May 18, 2026