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Vive SUP1052BLU

by Vive Health LLC

Part of a family of 17 devices: see the family page

Ref SUP1052BLU

Vive SUP1052BLU is a Class I device made by Vive Health LLC, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 081832302SPLINTHANDA9) and listed in FDA GUDID since 11 Jun 2026 (UDI-DI 00810226440272), 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 Number081832302SPLINTHANDA9 Basic UDI-DI 00810226440272UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810226440272 UDI-DI Date11 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081832302SPLINTHANDA9 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00810226440272 listed 11 Jun 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810226440272
  2. Registered EUDAMED 081832302SPLINTHANDA9

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  • Withdrawn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
Hand/finger splint, reusable
Device name
Finger Splint
Model / reference
SUP1052BLU
Primary DI / UDI-DI
00810226440272
Basic UDI-DI
081832302SPLINTHANDA9
FDA product code
ILH
EMDN code
Y060603 Fingers orthoses
GMDN term
Hand/finger splint, reusable
Device class
Class I
Regulation number
890.3475
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under FINGERS 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)