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Luvis

by Dentis Co., Ltd 7 variants

Ref D-C-LVST-V3-202602-ENGModel ST500, ST500E, ST300, ST300E

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800313230406 UDI-DI Date3 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000530STBD Basic UDI-DI 08800313230406UDI-DIDate2 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Luvis EUDAMED
ST300 Series GUDID
Generic Name
Electromechanical operating table base
Device Name
Operating Table
Model / Reference
ST500, ST500E, ST300, ST300E, D-C-LVST-V3-202602-ENG
Primary DI / UDI-DI
08800313230406
Basic UDI-DI
88000530STBD
Direct Marketing DI
08800313230406
FDA Product Code
GDC
EMDN Code
Z12011202 Operating tables
GMDN Term
Electromechanical operating table base
Device Class
Class I
Regulation Number
878.4960
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ST500, ST500E, ST300, ST300E
D-C-LVST-V3-202602-ENG
GUDID
ST300E

Manufacturer details

EUDAMED SRN
KR-MF-000012523
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Dentis Co., Ltd.

See all devices from Dentis Co., Ltd. →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No