Knee Brace
by Xiamen LongStar Medical Equipment Co., Ltd 82 variants
Ref FG-9004 SModel FG-1158,FG-9001,FG-9004,FG-9010,FG-9027,FG-9029,FG-9035,FG-9037,FG-9037-1,FG-9050,FG-9053,FG-9053-1,FG-9065,FG-9069,FG-PED003,FG-PED023,FG-PED024, etc.
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 | Number697600995KB001F2 06976009958588 | Date7 Jul 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- Withdrawn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
- Knee Brace
- Model / Reference
- FG-1158, FG-9001, FG-9004, FG-9010, FG-9027, FG-9029, FG-9035, FG-9037, FG-9037-1, FG-9050, FG-9053, FG-9053-1, FG-9065, FG-9069, FG-PED003, FG-PED023, FG-PED024, etc., FG-9004 S
- Primary DI / UDI-DI
- 06976009958588
- Basic UDI-DI
- 697600995KB001F2
- EMDN Code
- Y090618 Leg and knee protections (including socks for amputated legs)
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034315
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
From the manufacturer
Manufacturer's product page: Knee Brace Support
Other devices from Xiamen LongStar Medical Equipment Co., Ltd
See all devices from Xiamen LongStar Medical Equipment 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