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Vive SUP2096L

by Vive Health LLC

Part of a family of 45 devices: see the family page

Ref SUP2096L

Vive SUP2096L is a Class I device made by Vive Health LLC, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 081004198BRACEWRISTKF) and listed in FDA GUDID since 16 Feb 2023 (UDI-DI 00810041988430), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081004198BRACEWRISTKF Basic UDI-DI 00810041988430UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810041988430 UDI-DI Date16 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004198BRACEWRISTKF registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 00810041988430 listed 16 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810041988430
  2. Registered EUDAMED 081004198BRACEWRISTKF

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  • Withdrawn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
Vive
Generic name
Compression/pressure tubular garment
Device name
Wrist Hand Orthosis
Model / reference
SUP2096L
Primary DI / UDI-DI
00810041988430
Basic UDI-DI
081004198BRACEWRISTKF
FDA product code
FQL
EMDN code
Y060612 Wrist-hand orthoses
GMDN term
Compression/pressure tubular garment
Device class
Class I
Regulation number
880.5780
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Compression/pressure tubular garment

Similar devices in this category

Other devices filed under WRIST-HAND ORTHOSES.

Other devices from Vive Health LLC

See all devices from Vive Health LLC →

Properties

  • Over-the-counter
  • Premarket exempt
Other properties (23, all answered No)