HomeChinaGUANGDONG OPTOMEDIC TECHNOLOGIES,INC.

GUANGDONG OPTOMEDIC TECHNOLOGIES,INC.

China · 佛山 · www.optomedic.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-PR-000043365Unified social credit code 9144060007348267XQ

This company holds 29 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
29China registrations
Class I 1Class II 28
as of 2026-09-04
EUEuropean UnionEUDAMED
58UDI-DI device records
Class I 35Class IIa 22Class IIb 1
USUnited StatesFDA openFDA
7listed device types
Class I 0Class II 7Class III 0
plus 10 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union58 raw hits, 0 excluded, 58 confirmed
United States10 registration records, 9 510(k), 0 PMA, 1 excluded
China29 certificates (Class III 0 / II 28 / I 1), as of 2026-09-04
Manufacturer names merged into this page: GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.

Regulatory identity

EU manufacturer SRN
CN-PR-000043365
EU authorised representative
Share info GmbH
Unified social credit code
9144060007348267XQ
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
129
Website
www.optomedic.com
Product categories
医用成像器械医用影像

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2013-07-30
Registered capital
CNY 48,306,280
Paid-in capital
CNY 48,306,280
Legal form
Joint-stock limited company (foreign-invested)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-05-13
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMERecognised enterprise technology centreInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

52023 · K231342
22024 · K242513
12025 · K252697
12026 · K252318

FDA listed device types

Laparoscope And Accessories, Gynecologic, Reprocessed 1Led Light Source 1Confocal Optical Imaging 1Laparoscope, Gynecologic (And Accessories) 1System, X-Ray, Angiographic 1Laparoscope, General & Plastic Surgery 1Insufflator, Laparoscopic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262210825三维可视化医学影像处理工作站软件Class II
CN粤械注准202620604124K三维电子胸腹腔内窥镜Class II
CN粤械注准20262060291图像处理器Class II
CN粤械注准20252061424胸腹腔内窥镜Class II
EU06973031299191Insufflator(with Insufflation Tube and Gas Filter)Class IIb
EU06973031299245OptoMedic 4K 3D Medical MonitorClass I
EU06973031299252OptoMedic 4K UHD Medical MonitorClass I
EU06973031299368Stellar Light SourceClass IIa
USK252318Insufflator (OPTO-IFL1000)2026-04-16
USK2526973D Laparoscope2025-10-29
USK242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)2024-10-23

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