Medical Sodium Hyaluronate Silicone Scar Gel
by Zhengzhou Heji Biotechnology Co., Ltd. 48 variants
Model 3g/pc, 5g/pc, 8g/pc, 10g/pc, 12g/pc, 15g/pc, 16g/pc,18g/pc, 20g/pc, 25g/pc, 30g/, 35g/pc, 40g/pc, 45g/pc, 50g/pc, 60g/pc
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 | Number69718460601XR 16971846069968 | Date30 Jun 2026 | 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- Withdrawn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
- Medical Sodium Hyaluronate Silicone Scar Gel
- Model / Reference
- 3g/pc, 5g/pc, 8g/pc, 10g/pc, 12g/pc, 15g/pc, 16g/pc, 18g/pc, 20g/pc, 25g/pc, 30g/, 35g/pc, 40g/pc, 45g/pc, 50g/pc, 60g/pc
- Primary DI / UDI-DI
- 16971846069968
- Basic UDI-DI
- 69718460601XR
- EMDN Code
- M04040701 Silicone dressings, non-combined
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000056670
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Zhengzhou Heji Biotechnology Co., Ltd.
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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