Back Brace
by Xiamen LongStar Medical Equipment Co., Ltd 46 variants
Ref FG-B020 LModel 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 L) 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 06976009951398 | 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- Withdrawn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 L
- Primary DI / UDI-DI
- 06976009951398
- 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
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