Silicone Gel Dressing
by Shenzhen Canglv Technology Co., Ltd. 2 variants
Ref Silicone gel scar repair patchModel Silicone gel scar repair patch, Silicone gel waterproof patch, Silicone gel fixed patch, Silicone gel acupoint patch, Silicone gel bedsore patch, Silicone gel blank patch, Skin color silicone gel patch, Silicone gel pu membrane coiled material
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697928701SGD001QG 06979287010078 | Date13 Nov 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Silicone Gel Dressing
- Model / Reference
- Silicone gel scar repair patch, Silicone gel waterproof patch, Silicone gel fixed patch, Silicone gel acupoint patch, Silicone gel bedsore patch, Silicone gel blank patch, Skin color silicone gel patch, Silicone gel pu membrane coiled material
- Primary DI / UDI-DI
- 06979287010078
- Basic UDI-DI
- 697928701SGD001QG
- EMDN Code
- M04040701 Silicone dressings, non-combined
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000050314
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Canglv Technology Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No