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adhesive wound dressing
EUDAMEDClass I (EU MDR)
Ref N/AModel 6*7CM blue/6*7CM green / 6*10CM*10*10CM/10*15CM
Identity
- Device Name
- adhesive wound dressing EUDAMED
- Model / Reference
- 6*7CM blue/6*7CM green / 6*10CM*10*10CM/10*15CM EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958689900139 EUDAMED
- Basic UDI-DI
- 69586899SAE0010001SL EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
adhesive wound dressing by Pujiang Jianyu Sanitary Products 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 | 69586899SAE0010001SL | Class I | Active |
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Manufacturer
- Manufacturer
- Pujiang Jianyu Sanitary Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000043742
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6326b6f9-8b27-416b-8dc2-e1471f8bc306 61 fields · synced Oct 6, 2026