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Ankle Brace And Night Splint

by Xiamen LongStar Medical Equipment Co., Ltd 69 variants

Ref FG-6002 SModel FG-1002,FG-1002-1,FG-1003,FG-1004,FG-1007,FG-1007-2,FG-1007-3,FG-1011,FG-1026,FG-1021,FG-1022,FG-6002,FG-6004,FG-6005,FG-6008,FG-6023,FG-6024,FG-6026,PE-8806,FG-PED014,FG-1247,FG-A001,FG-A002,FG-A003,FG-A004,FG-A005,FG-A005-1,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 Number697600995ABANSJV Basic UDI-DI 06976009959288UDI-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  • Withdrawn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
Ankle Brace And Night Splint
Model / Reference
FG-1002, FG-1002-1, FG-1003, FG-1004, FG-1007, FG-1007-2, FG-1007-3, FG-1011, FG-1026, FG-1021, FG-1022, FG-6002, FG-6004, FG-6005, FG-6008, FG-6023, FG-6024, FG-6026, PE-8806, FG-PED014, FG-1247, FG-A001, FG-A002, FG-A003, FG-A004, FG-A005, FG-A005-1, etc., FG-6002 S
Primary DI / UDI-DI
06976009959288
Basic UDI-DI
697600995ABANSJV
EMDN Code
Y090618 Leg and knee protections (including socks for amputated legs)
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: Medical Ankle 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