Insole

by Dongguan Jiuhui Industrial Limited 469 variants

Model JHW-005

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697642557in1752P Basic UDI-DI 06976425571750UDI-DI	Date25 Apr 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Insole
Model / Reference: JHW-005

Primary DI / UDI-DI: 06976425571750
Basic UDI-DI: 697642557in1752P
EMDN Code: Y061203 Orthoses, foot (including insoles and inserts)

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000035646
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Properties

Reusable
Administering Medicine
Measuring Function

Other properties (10)

Sterile: No
Implantable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Incorporates Medicinal Product: No