Kerato refractometer

GUDID 06973211071876

CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

Automated ophthalmic refractometer
Primary Device ID06973211071876
NIH Device Record Key2fff8cc3-f202-4151-bd41-4e213d05d3bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerato refractometer
Version Model NumberSK-6800B
Company DUNS545824560
Company NameCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
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
GS106973211071876 [Primary]

FDA Product Code

HKORefractometer, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-26
Device Publish Date2025-08-18

On-Brand Devices [Kerato refractometer]

06973211071876SK-6800B
06973211071869SK-6800A

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