Identity
- Device Name
- Wound dressings EUDAMED
- Model / Reference
- PU type EUDAMED10cm×15cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974692681288 EUDAMED
- Basic UDI-DI
- 697469268300018U EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Wound dressings by Jiangsu Guangyi Medical Dressing Co., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697469268300018U | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Guangyi Medical Dressing Co., Ltd.
- EUDAMED SRN
- CN-MF-000009827
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3fe55af6-c188-486f-8b7c-ec75b0673ba2 61 fields · synced Jun 18, 2026