Optomed Lumo Camera set

GUDID 06430046260993

Optomed Lumo Camera set

Optomed Oy

Ophthalmic fundus camera
Primary Device ID06430046260993
NIH Device Record Keyf1d5d148-fba4-4b88-92d5-2b60881720aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptomed Lumo Camera set
Version Model Number60102406A
Company DUNS401968495
Company NameOptomed Oy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430046260993 [Primary]

FDA Product Code

PJZCamera, Ophthalmic, General-Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-21
Device Publish Date2025-11-13

Devices Manufactured by Optomed Oy

06430046260597 - Smartscope Pro full set2025-11-21 Optomed Smartscope Pro full set M5WEY4ES2
06430046260689 - Smartscope Pro retinal set2025-11-21 Optomed Smartscope Pro retinal set M5WEY4
06430046260993 - Optomed Lumo Camera set2025-11-21Optomed Lumo Camera set
06430046260993 - Optomed Lumo Camera set2025-11-21 Optomed Lumo Camera set
06430046260658 - Pictor M5WEY4ES2 Volk FN2021-11-23 Volk Pictor Plus full set
06430046260672 - Pictor M5WEY4 Volk FN2021-11-23 Volk Pictor Plus retinal set
06430046260757 - Optomed Aurora full set2019-12-12 Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.
06430046260795 - Optomed Aurora retinal set2019-12-12 Optomed Aurora retinal set including Aurora camera and Aurora retinal module.
06430046260870 - Volk Pictor Prestige full set2019-12-12 Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Retina module and Pictor Prestige Anterior modul

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.