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Luvis

by Dentis Co., Ltd 7 variants

Ref D-C-LVSL-V5-202602-ENGModel L200, M210, M200

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 Number08800053097888 UDI-DI Date7 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number88000530LM200AV Basic UDI-DI 08800053097888UDI-DIDate26 Jan 2022RegisteredStatusActive

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  • Withdrawn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
LUVIS-M210 Series GUDID
Generic Name
Operating room light system
Device Name
Surgical Luminaire
Model / Reference
L200 EUDAMED
M210 EUDAMED
M200 EUDAMED
D-C-LVSL-V5-202602-ENG EUDAMED
M210-N3SS000 GUDID
Primary DI / UDI-DI
08800053097888
Basic UDI-DI
88000530LM200AV
Direct Marketing DI
08800053097888
FDA Product Code
FTD
EMDN Code
Z12010701 Fixed scialytic lamps
GMDN Term
Operating room light system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4580
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
L200, M210, M200
D-C-LVSL-V5-202602-ENG
GUDID
M210-N3SS000
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No