Identity
- Trade Name
- Silicone Foam Dressing EUDAMED
- Model / Reference
- Type B EUDAMED1204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945296006524 EUDAMED
- Basic UDI-DI
- 69452960SiFoDress00B79 EUDAMED
- EMDN Code
- M04040702 SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Silicone Foam Dressing by Wuhan Huawei Technology Co., Ltd — Class IIa — 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 | 69452960SiFoDress00B79 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wuhan Huawei Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000014668
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 87cfcf72-5a57-497f-9944-a600d322db99 61 fields · synced Jul 13, 2026