Orteza kończyny dolnej OG-WK003 (M)

by Orthoguard Sp. z o.o.

Ref M

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number5905957672OGWK00QM Basic UDI-DI 05905957672155UDI-DI	Date24 Jan 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Withdrawn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: Orteza kończyny dolnej
Model / Reference: M

Primary DI / UDI-DI: 05905957672155
Basic UDI-DI: 5905957672OGWK00QM
Direct Marketing DI: 05905957672155
EMDN Code: Y06120601 Passive ankle-foot orthoses

Device Class: Class I
EU market of registration: Poland

Manufacturer details

EUDAMED SRN: PL-MF-000050865

From the manufacturer

Manufacturer's product page: Orteza OG-WK003

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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