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spinal brace

by Shijiazhuang aofeite imp&exp co., ltd 3 variants

Ref AFT-1073Model AFT-1073 AFT1074 AFT-1075 AFT-1076 AFT-1081 AFT-1085

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69537519ANT01SB Basic UDI-DI 06953768902502UDI-DIDate7 Nov 2024RegisteredStatusActive

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  • Withdrawn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
spinal brace
Model / Reference
AFT-1073 AFT1074 AFT-1075 AFT-1076 AFT-1081 AFT-1085, AFT-1073
Primary DI / UDI-DI
06953768902502
Basic UDI-DI
69537519ANT01SB
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000011825
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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