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Mach8™ - Ankle Brace

by Thrive Orthopedics 5 variants

Ref MACH-M

Mach8™ - Ankle Brace (MACH-M) is a Class I device made by Thrive Orthopedics, registered in EUDAMED on 18 Mar 2026 (Basic UDI-DI 081007919MACH8Z5) and listed in FDA GUDID since 8 Dec 2023 (UDI-DI 00810079190959), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081007919MACH8Z5 Basic UDI-DI 00810079190959UDI-DIDate18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810079190959 UDI-DI Date8 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081007919MACH8Z5 registered 18 Mar 2026 Active
  • FDA GUDID UDI-DI 00810079190959 listed 8 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810079190959
  2. Registered EUDAMED 081007919MACH8Z5

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  • Withdrawn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
Mach8™ - Ankle Brace
Model / reference
MACH-M
Primary DI / UDI-DI
00810079190959
Basic UDI-DI
081007919MACH8Z5
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 registration type
Standard device
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

Related devices

Category: Ankle/foot orthosis

Similar devices in this category

Other devices filed under PASSIVE ANKLE-FOOT ORTHOSES.

Other devices from Thrive Orthopedics

See all devices from Thrive Orthopedics →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)