Back Brace
by Xiamen LongStar Medical Equipment Co., Ltd 46 variants
Ref FG-B020 MModel FG-8011,FG-8018,FG-8018-1,FG-8028,FG-8022,FG-1009,FG-1122,FG-PED008,FG-PED009,FG-PED021,FG-PED022,FG-PED023,FG-PE8617,FG-K023,FG-B001,FG-B002,FG-B002-2,FG-B003,FG-B004,FG-B005,FG-B006,FG-B007,FG-B008,FG-B009,FG-B010,FG-B011,FG-B012,etc.
Back Brace (FG-B020 M) is a Class I device made by Xiamen LongStar Medical Equipment Co., Ltd, registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 697600995BB001BX), active as of 7 Nov 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 | Number697600995BB001BX 06976009951381 | Date7 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 697600995BB001BX
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- Withdrawn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
- Back Brace
- Model / reference
- FG-8011, FG-8018, FG-8018-1, FG-8028, FG-8022, FG-1009, FG-1122, FG-PED008, FG-PED009, FG-PED021, FG-PED022, FG-PED023, FG-PE8617, FG-K023, FG-B001, FG-B002, FG-B002-2, FG-B003, FG-B004, FG-B005, FG-B006, FG-B007, FG-B008, FG-B009, FG-B010, FG-B011, FG-B012, etc., FG-B020 M
- Primary DI / UDI-DI
- 06976009951381
- Basic UDI-DI
- 697600995BB001BX
- EMDN code
- Y090699 Devices for body protection - other
- 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: Back Brace
Similar devices in this category
Other devices filed under DEVICES FOR BODY PROTECTION - OTHER.
- ΣΠΑΣΟΥΑΡ 0344 by ΑΝΑΤΟΜΙΚ ΧΕΛΠ ΑΝΩΝΥΜΗ ΕΤΑΙΡΙΑ ΕΜΠΟΡΙΑΣ ΚΑΙ ΚΑΤΑΣΚΕΥΗΣ ΟΡΘΟΠΕΔΙΚΩΝ ΕΙΔΩΝ Α.Ε.
- Heel/Elbow Slip Over, XXLarge 15245 by Silipos Holding LLC.
- Cervical Collar(Neck Traction) Neck Traction-S by ANPING HUAKANG MEDICAL PRODUCTS FACTORY
- CONFEZIONE 1 POLPACCERA Nero S WEAR05-BLK-01 by D.Fenstec s.r.l.
- Cervical Collar(Foam Neck Brace) Foam Neck Brace-XXXL by ANPING HUAKANG MEDICAL PRODUCTS FACTORY
- POSTURE CORRECTOR QH-1079 by Yangzhou Qionghua Sports Goods Co., Ltd
- Half Coated Body Sleeve, 5" Width x 3.61 Yards, 1roll/bag 10945 by Silipos Holding LLC.
- CONFEZIONE 1 POLPACCERA Nero L WEAR05-BLK-03 by D.Fenstec s.r.l.
- 2MM 46 X 61CM NEOPRENE 8728BLAUN by Elastic Therapy
- Back Brace Y201 by Guangzhou Yifangjia Textile And Garment Technology Co., Ltd.
Other devices from Xiamen LongStar Medical Equipment Co., Ltd
See all devices from Xiamen LongStar Medical Equipment Co., Ltd →