U-Profile Orthotic Insoles

by Welsheng Corp. 4 variants

Ref 309-M-1

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	Number471988489CL106GS Basic UDI-DI 04719884890343UDI-DI	Date4 Sep 2023Registered	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Withdrawn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: Foot Cushion
Model / Reference: 309-M-1

Primary DI / UDI-DI: 04719884890343
Basic UDI-DI: 471988489CL106GS
EMDN Code: Y061203 Orthoses, foot (including insoles and inserts)

Device Class: Class I
EU market of registration: Malta

Manufacturer details

EUDAMED SRN: TW-MF-000005197
Authorised representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

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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