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Back Brace

by Xiamen LongStar Medical Equipment Co., Ltd 42 variants

Ref FG-B019 XLModel 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.

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697600995BB001BX Basic UDI-DI 06976009958380UDI-DIDate7 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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-B019 XL
Primary DI / UDI-DI
06976009958380
Basic UDI-DI
697600995BB001BX
EMDN Code
Y090699 Devices for body protection - other
Device Class
Class I
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

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