Orteza stawu skokowego (S)

by Orthoguard Maciej Tomczuk

Ref OG-AN001

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	Number5903981322ortezyRM Basic UDI-DI 05903981322091UDI-DI	Date23 Dec 2021Registered	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Withdrawn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: Ortezy
Model / Reference: OG-AN001

Primary DI / UDI-DI: 05903981322091
Basic UDI-DI: 5903981322ortezyRM
EMDN Code: Y06120601 Passive ankle-foot orthoses

Device Class: Class I
EU market of registration: Poland

Manufacturer details

EUDAMED SRN: PL-MF-000002247

Other devices from Orthoguard Maciej Tomczuk

Orteza kończyny dolnej 43 cm (M)

Class I
Orteza kończyny dolnej 28 cm (XS)

Class I
Orteza nadgarstka prawa (L)

Class I
Orteza nadgarstka lewa (S)

Class I
Orteza kończyny dolnej 43 cm (XL)

Class I
Opaska elastyczna stawu kolanowego (M)

Class I

See all devices from Orthoguard Maciej Tomczuk →

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