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LUVIS-L400 Series L400-N3DS400

by Dentis Co., Ltd United States GUDID

Product code FTD

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800266947000 UDI-DIDate7 Sep 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
LUVIS-L400 Series
Generic Name
Operating room light system
Model / Reference
L400-N3DS400
Primary DI / UDI-DI
08800266947000
FDA Product Code
FTD
GMDN Term
Operating room light system
Device Class
Class II
Regulation Number
878.4580
Commercial Distribution
In Commercial Distribution

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date
Other properties (11)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (1)

  • FDA UDI 127beafa-10d7-4f99-b5bc-d8e968960f84 33 fields · synced 23 Oct 2026