Lower limb brace

by Shijiazhuang aofeite imp&exp co., ltd 14 variants

Ref Comfort bütyökvédő (L) ZSN6 GYVFCBL

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

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69748LLB001LY Basic UDI-DI 06953751901352UDI-DI	Date7 May 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Lower limb brace
Model / Reference: Comfort bütyökvédő (L) ZSN6 GYVFCBL

Primary DI / UDI-DI: 06953751901352
Basic UDI-DI: 69748LLB001LY
EMDN Code: Y061203 Orthoses, foot (including insoles and inserts)

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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Class I
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Shoulder brace

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See all devices from Shijiazhuang aofeite imp&exp 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