Identity
- Trade Name
- transparent dressing EUDAMED
- Device Name
- Sterile Adhesive Surgical Dressing EUDAMED
- Model / Reference
- 160607 EUDAMED161012 EUDAMED161225 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031815160814 EUDAMED04031815161019 EUDAMED04031815161316 EUDAMED
- Basic UDI-DI
- 69593857SASD0000013M EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
transparent dressing by Zhende Medical 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 | 69593857SASD0000013M | Class I | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 450328a2-5d85-455f-a479-647686b53fb6 61 fields · synced Jul 26, 2026
- EUDAMED ed3bcc2d-1815-4be1-b21d-37e80fe53ffb 61 fields · synced May 17, 2026
- EUDAMED ec01b75d-1111-44fa-b3e5-5eabe2b7e394 61 fields · synced May 18, 2026