Silicone Wound Contact Dressing
by Huizhou Foryou Medical Devices Co., Ltd. 11 variants
Ref SC100075S-P, SC100100S-P, SC175100S, QL-IS7X5FU, SN7510, QL-IS10X10DF, SC100075DW-P, QL-IS10X75FU, SC175100S-P, QL-IS175X10DF
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69406101SC00027P | Date3 Jan 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Silicone Wound Contact Dressing
- Model / Reference
- SC100075S-P, SC100100S-P, SC175100S, QL-IS7X5FU, SN7510, QL-IS10X10DF, SC100075DW-P, QL-IS10X75FU, SC175100S-P, QL-IS175X10DF
- Primary DI / UDI-DI
- 06940610105884, 06940610103118, 06940610105587, 06940610156497, 06940610129514, 06940610156640, 06940610111151, 06940610156558, 06940610105907, 06940610156671
- Basic UDI-DI
- 69406101SC00027P, 69406101SC00067X
- Unit of Use DI
- 06940610105877, 06940610111991, 06940610105570, 06940610156480, 06940610129507, 06940610156633, 06940610111144, 06940610156541, 06940610105891, 06940610156664
- EMDN Code
- M04040701 Silicone dressings, non-combined
- Device Class
- Class IIb
- EU market of registration
- SwedenNorwayTürkiyePortugalAustria
Manufacturer details
- EUDAMED SRN
- CN-MF-000007344
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Huizhou Foryou Medical Devices Co., Ltd.
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Properties
Other properties (12)
- 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