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HealthCare Professional Kit

by Ora Medical Inc.

Ref LVHP-0100

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00628719745014 UDI-DI Date22 Nov 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number628719745LVZU Basic UDI-DI 00628719745014UDI-DIDate24 Oct 2024RegisteredStatusActive

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  • Withdrawn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
HealthCare Professional Kit EUDAMED
Levity GUDID
Generic Name
Hands-free disability-assistive walker
Model / Ref / Catalog
LVHP-0100
Primary DI / UDI-DI
00628719745014
Basic UDI-DI
628719745LVZU
FDA Product Code
ITJ
EMDN Code
Y1299 Personal mobility devices - other
GMDN Term
Hands-free disability-assistive walker
Device Class
Class I
Regulation Number
890.3825
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CA-MF-000044148
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Ora Médical Inc

See all devices from Ora Médical Inc →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • 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
  • Manufacturing Date: No