Identity
- Device Name
- Silicone Gel Sheet EUDAMED
- Model / Reference
- J-12cm×6cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972949025052 EUDAMED
- Basic UDI-DI
- 697294902JYSX5 EUDAMED
- Direct Marketing DI
- 06972949025052 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Sheet by Hangzhou R&L Medical Device 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 | 697294902JYSX5 | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou R&L Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000046648
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 41f80c62-d2b8-4a0e-8ada-99a026307c6e 61 fields · synced Jun 18, 2026