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FlexiOH

by Jc Orthoheal Private Limited 41 variants

Ref FAC00S

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 Number8908014765FLXFY Basic UDI-DI 89080147652864UDI-DIDate27 Jul 2022RegisteredStatusActive

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  • Withdrawn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
FlexiOH - Light Cured Polymer Immobilizer
Model / Reference
FAC00S
Primary DI / UDI-DI
89080147652864
Basic UDI-DI
8908014765FLXFY
EMDN Code
M030599 Immobilisation systems and devices - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000026318
Authorised representative
AF Pharma Service Europe SL ES-AR-000018076

Other devices from Jc Orthoheal Private Limited

See all devices from Jc Orthoheal Private Limited →

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