Identity
- Trade Name
- Cohesive bandage EUDAMED
- Device Name
- Medical Bandage EUDAMED
- Model / Reference
- Crepe EUDAMED543435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717928543435 EUDAMED
- Basic UDI-DI
- 69380562MB003KU EUDAMED
- Unit of Use DI
- 88717928543431 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
Yes
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
Cohesive bandage by Zhejiang Hongyu Medical Commodity 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 | 69380562MB003KU | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd
- EUDAMED SRN
- CN-MF-000008204
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED d55b0531-8ec4-4736-a24b-5bfa92bb8e80 61 fields · synced Oct 6, 2026