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FlexiOH Short Arm Immobilizer XXS

by Jc Orthoheal Private Limited

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08908014765002 UDI-DI Date29 Jun 2020ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
FlexiOH
Generic Name
Hand orthosis
Model / Reference
Short Arm Immobilizer XXS
Description
FlexiOH Short Arm Immobilizer is indicated for Distal radius stable fracture , wrist fracture and wrist sprain.
Primary DI / UDI-DI
08908014765002
FDA Product Code
IQI
GMDN Term
Hand orthosis
Device Class
Class I
Regulation Number
890.3475
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No