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upper limb brace

by Guanchi Technology (Hebei) Co., Ltd. 20 variants

Ref GCSZ-5015Model GCSZ-5000~GCSZ-5049

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 Number697781226GCSZ001XR Basic UDI-DI 06977812261650UDI-DIDate10 Dec 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  • Withdrawn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
upper limb brace
Model / Reference
GCSZ-5000~GCSZ-5049, GCSZ-5015
Primary DI / UDI-DI
06977812261650
Basic UDI-DI
697781226GCSZ001XR
EMDN Code
Y061219 Chest-lumb-sacral-hip-knee-ankle-foot orthoses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000044147
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Guanchi Technology (Hebei) Co., Ltd.

See all devices from Guanchi Technology (Hebei) 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