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Kantapaakuppi

by Prim, S.A. 3 variants

Ref MI282 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number843404825PRODUCTOSPIEV7 Basic UDI-DI 08434048049479UDI-DIDate22 May 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Ortesis Podológicas/Podiatry Orthoses
Model / Reference
MI282 M
Primary DI / UDI-DI
08434048049479
Basic UDI-DI
843404825PRODUCTOSPIEV7
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
ES-MF-000004651

Related devices

Category: Orthotic insole, prefabricated, non-antimicrobial

Other devices from Prim S.A.

See all devices from Prim S.A. →

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