Refraction Unit

GUDID 05907642694480

MDT SP Z O O

Ophthalmic examination station
Primary Device ID05907642694480
NIH Device Record Keyc27b7918-5222-4828-8cf5-89b744725787
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefraction Unit
Version Model NumberPRO 1000 EVO
Company DUNS366126408
Company NameMDT SP Z O O
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 Datetrue
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
GS105907642694480 [Primary]

FDA Product Code

HMFStand, Instrument, Ac-Powered, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-24
Device Publish Date2025-07-16

On-Brand Devices [Refraction Unit]

05907642694442UNIQ
05907642694596TRU-2000
05907642694589TRU-1000
05907642694565TRU-800
05907642694541SMART PLUS
05907642694534EASY
05907642694510ECO PLUS
05907642694497TRU-2500
05907642694480PRO 1000 EVO
05907642694473PRO 1000
05907642694466PRO 500
05907642694459EASY PLUS

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