FDA.reportPublic FDA data

GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30299684143029968414GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.1N2026-01-01Suite 503, Building A, Golden Valley Intellicreation Community No. 2 Yonganbei Street, Daxu, Guicheng,Nanhai Foshan Guangdong CN 528200

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3209341500394653K2526973D LaparoscopeGCJ2025-10-29
3209341332838701K252318Insufflator (OPTO-IFL1000)HIF2026-04-16
3209341207432475K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)GCJ2024-10-23
3209341882325249K241530Stellar Imaging SystemGCJ2024-08-07
3209341430151472K231342Insufflator (OPTO-IFL1000)HIF2023-09-20
3209342002276728K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)GCJ2023-07-06
3209341610901399K230407FloNavi Open Field Fluorescence Imaging SystemOWN2023-07-17
3209341508865415K221861FloNavi Endoscopic Fluorescence Imaging SystemGCJ2023-02-18
3209341651630175K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGCJ2023-02-02
3209341752219837

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ62025-10-29
HIF22026-04-16
OWN12023-07-17

PMN#

GUDID#

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