SYSEYE

GUDID 06973009600011

Chongqing Bio NewVision Medical Equipment Ltd.

Ophthalmic fundus camera
Primary Device ID06973009600011
NIH Device Record Keyf478a9ca-a230-48d3-a6a4-ad8d8cc7dc5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYSEYE
Version Model NumberRetiCam 3100
Company DUNS540754972
Company NameChongqing Bio NewVision Medical Equipment Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973009600011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKICamera, Ophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-21
Device Publish Date2020-02-13

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