Identity
- Device Name
- SILICONE GEL DRESSING EUDAMED
- Model / Reference
- SILICONE SCAR TAPE 4cm*3m EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795056846 EUDAMED
- Basic UDI-DI
- 697479505684R8 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Silicone Gel Dressing by Henan Maidingkang Medical Technology 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 | 697479505684R8 | Class I | Active |
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Manufacturer
- Manufacturer
- Henan Maidingkang Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018827
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 6fd5642e-5215-4ea6-95d4-b2117db4c4ad 61 fields · synced Jun 19, 2026