Medical Care Pie Plano FM8 280 39/40

Ref FM8 280 39/40Model FLEXOR MEDICAL CARE PIE PLANO

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	Number84355156FM8280D8 Basic UDI-DI 08435515600254UDI-DI	Date28 Jul 2025Registered	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Withdrawn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: Flexor Medical Care Pie Plano
Model / Reference: FLEXOR MEDICAL CARE PIE PLANO, FM8 280 39/40

Primary DI / UDI-DI: 08435515600254
Basic UDI-DI: 84355156FM8280D8
EMDN Code: Y061203 Orthoses, foot (including insoles and inserts)

Device Class: Class I
EU market of registration: Spain

Manufacturer details

EUDAMED SRN: ES-MF-000042891

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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