Identity
- Trade Name
- ABE Wundverband EUDAMED
- Device Name
- Sterile Adhesive Surgical Dressing EUDAMED
- Model / Reference
- 4768 EUDAMED4762 EUDAMED4764 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250016499909 EUDAMED04250016499879 EUDAMED04250016499886 EUDAMED
- Basic UDI-DI
- 69593857SASD0000013M EUDAMED
- EMDN Code
- M04010101 NON-WOVEN 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
ABE Wundverband 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 1e7a2fc2-61b5-4762-a938-88a154f4005e 61 fields · synced Jul 21, 2026
- EUDAMED a1fc70d4-4c99-4967-87cc-33dd40d1c9a1 61 fields · synced May 18, 2026
- EUDAMED 6ec7c42b-763c-42d1-9bd7-09dd21242ccd 61 fields · synced May 18, 2026