Skip to content

CoreTech SUP3116R

by Vive Health LLC

Ref SUP3116R

CoreTech SUP3116R is a Class I device made by Vive Health LLC, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 081017888ORTHOSISHIPSS) and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 00810178884759), 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 Number081017888ORTHOSISHIPSS Basic UDI-DI 00810178884759UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810178884759 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081017888ORTHOSISHIPSS registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00810178884759 listed 27 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810178884759
  2. Registered EUDAMED 081017888ORTHOSISHIPSS

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  • Withdrawn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
CoreTech
Generic name
Hip orthosis
Device name
Hip Orthosis
Model / reference
SUP3116R
Primary DI / UDI-DI
00810178884759
Basic UDI-DI
081017888ORTHOSISHIPSS
FDA product code
ITS
EMDN code
Y061215 Hip orthoses (including abduction orthoses)
GMDN term
Hip orthosis
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 HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES).

Other devices from Vive Health LLC

See all devices from Vive Health LLC →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)