Knee Brace
by Xiamen LongStar Medical Equipment Co., Ltd 82 variants
Part of a family of 82 devices: see the family page
Ref FG-K016 LModel 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.
Knee Brace (FG-K016 L) is a Class I device made by Xiamen LongStar Medical Equipment Co., Ltd, registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 697600995KB001F2), active as of 24 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697600995KB001F2 06976009959257 | Date7 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 697600995KB001F2
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- Withdrawn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-K016 L
- Primary DI / UDI-DI
- 06976009959257
- Basic UDI-DI
- 697600995KB001F2
- EMDN code
- Y090618 Leg and knee protections (including socks for amputated legs)
- Device class
- Class I
- EU registration type
- Standard device
- EU 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
Similar devices in this category
Other devices filed under LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS).
- Duragel Cushion Liner, Tapered, 6mm, Medium+ 18247 by Silipos Holding LLC.
- Distal Roll-On, Wide, 2/Bag 1497 by Silipos Holding LLC.
- ELASTIC KNEE SUPPORT B703-S by Jiangsu Reak Healthy Articles Co., Ltd.
- ANKLE SUPPORT 6906 by JIANGSU MEDAKOR HEALTHY ARTICLES CO., LTD.
- Hinged Knee Brace HX042/035 by Shenzhen Haofan Network Technology Co., LTD.
- Elastic Ankle Support B904-S by Jiangsu Reak Healthy Articles Co., Ltd.
Other devices from Xiamen LongStar Medical Equipment Co., Ltd
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