Ortopedické vložky pre pozdĺžne a priečne ploché nohy, koža, pánske

by PROTETIKA, a.s. 7 variants

Ref 8585003427006Model Insoles

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number858500J52720KOZ42QU Basic UDI-DI 08585003427006UDI-DI	Date19 Jun 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Withdrawn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

Model / Reference: Insoles, 8585003427006

Primary DI / UDI-DI: 08585003427006
Basic UDI-DI: 858500J52720KOZ42QU
Direct Marketing DI: 08585003427006
EMDN Code: Y061203 Orthoses, foot (including insoles and inserts)

Device Class: Class I
EU market of registration: Slovakia

Manufacturer details

EUDAMED SRN: SK-MF-000004489

Other devices from PROTETIKA, a.s.

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Class I
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Class I
Pás bederní neoprenový, PA-701

Class I
Límec fixační latexový, Typ 7, 8 cm

Class I
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Ortopedické vložky pre priečne ploché nohy, multiform, dámske

Class I

See all devices from PROTETIKA, a.s. →

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