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F5 Super Flex Carbon Fiber AFO

by Thrive Orthopedics 4 variants

Ref SFXSRT

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number81007919SFF5AFOK7 Basic UDI-DI 00810079192946UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810079192946 UDI-DI Date27 May 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Model / Reference
SFXSRT
Primary DI / UDI-DI
00810079192946
Basic UDI-DI
81007919SFF5AFOK7
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

Manufacturer details

EUDAMED SRN
US-MF-000026394
Authorised representative
Code of Practice AB SE-AR-000003002

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