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Thrive Orthopedics FCCIM10

by Thrive Orthopedics

Ref FCCIM10

Active European Union. Also listed in GUDID (US).

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00810079192694 UDI-DI Date27 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0081007919FLXCFIU8 Basic UDI-DI 00810079192694UDI-DIDate20 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Thrive Orthopedics
Generic Name
Ankle/foot orthosis
Device Name
Contoured Carbon Insolde
Model / Reference
FCCIM10
Primary DI / UDI-DI
00810079192694
Basic UDI-DI
0081007919FLXCFIU8
FDA Product Code
IQI
EMDN Code
Y06120601 Passive ankle-foot orthoses
GMDN Term
Ankle/foot orthosis
Device Class
Class I
Regulation Number
890.3475
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Other devices from Thrive Orthopedics

See all devices from Thrive Orthopedics →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No