Guangdong Optomedic Technologies, Inc.
Manufacturer and brand owner in Foshan, Guangdong, China. 7 device types, 21 products catalogued, 9 clearances.
Guangdong Optomedic Technologies, Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Led Light Source, Confocal Optical Imaging and 5 other device types. 21 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
7device types registered with the FDA
21products catalogued under its own name
9510(k) clearances
Registration
| Registered name | GUANGDONG OPTOMEDIC TECHNOLOGIES, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3029968414 |
| FEI number | 3029968414 |
| DUNS | 544527790 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广东欧谱曼迪科技股份有限公司 |
|---|---|
| Unified social credit code | 9144060007348267XQ |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | Suite 503, Building A, Golden Valley Intellicreation Community |
| Postal code | 528200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Confocal Optical Imaging | Class 2 | FloNavi Open Field Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD3100H, OPTO-CHD3100E, OPTO-CAM214K, OPTO-CHD314KE | 2023 | 3 |
| Insufflator, Laparoscopic | Class 2 | Insufflator, Insufflator OPTO-IFL1000 | 2023 | 10 |
| Laparoscope And Accessories, Gynecologic, Reprocessed | Class 2 | Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533WA, 20533WC, 20533FA, 20533FC | 2023 | 2 |
| Laparoscope, General & Plastic Surgery | Class 2 | Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533WA, 20533WC, 20533FA, 20533FC, FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM214K, OPTO-CHD214KE, OPTO-CHD214KH, OPTO-LED214K, Endoscopic Fluorescence lmaging System 71-068-05 NIR-CA, 71-068-10 NIR-CA, 71-068-20 NIR-CA,71-182-30 NIR-CA, FloNavi Endoscopic Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD2100, OPTO-LED2100, Endoscopic Fluorescence lmaging System 71-182-30 NIR, 71-068-05 NIR, 71-068-10 NIR, 71-068-20 NIR, 3D Laparoscope: 21033SA,21033SC and 12 more | 2023 | 46 |
| Laparoscope, Gynecologic (And Accessories) | Class 2 | Laparoscope 21033FA, 21033FC, 21033WA, 21033WC, 20533WA, 20533WC, 20533FA, 20533FC | 2023 | 7 |
| Led Light Source | Class 2 | Light Source OPTO-LED104K | 2023 | 11 |
| System, X-Ray, Angiographic | Class 2 | FloNavi Open Field Fluorescence Imaging System OPTO-CAM2100, OPTO-CHD3100H, OPTO-CHD3100E, OPTO-CAM214K, OPTO-CHD314KE, Endoscopic Fluorescence lmaging System 71-068-05 NIR-CA, 71-068-10 NIR-CA, 71-068-20 NIR-CA,71-182-30 NIR-CA, FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K), Endoscopic Fluorescence lmaging System 71-182-30 NIR, 71-068-05 NIR, 71-068-10 NIR, 71-068-20 NIR | 2023 | 7 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Laparoscope | GCJ | 8 |
| Image Processing Unit | GCJ | 4 |
| 3D Laparoscope | GCJ | 4 |
| Veqtron | GCJ | 4 |
| Open Field Fluorescence Imaging Head | OWN | 3 |
| FloNavi Endoscopic Camera Head | GCJ | 2 |
| Insufflator | HIF | 2 |
| Endoscopic Fluorescence Camera Head | GCJ | 2 |
| FloNavi Light Source | GCJ | 2 |
| Insufflation tube | HIF | 2 |
| Stellar Light Source | GCJ | 2 |
| Stellar Exoscope | GCJ | 1 |
| Stellar Fluorescence Camera Head | GCJ | 1 |
| Stellar Camera Head | GCJ | 1 |
| Stellar 3D Camera Head | GCJ | 1 |
| Stellar 3D Fluorescence Camera Head | GCJ | 1 |
| FloNavi Camera Head | GCJ | 1 |
| Stellar Image Processing Unit | GCJ | 1 |
| Light Source | GCJ | 1 |
| WhtNavi Camera Head | GCJ | 1 |
| WhtNavi Light Source | NTN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252318 | 2026-04-16 | HIF | Traditional | This company |
| K252697 | 2025-10-29 | GCJ | Traditional | This company |
| K242513 | 2024-10-23 | GCJ | Traditional | This company |
| K241530 | 2024-08-07 | GCJ | Traditional | This company |
| K231342 | 2023-09-20 | HIF | Traditional | This company |
| K230407 | 2023-07-17 | OWN | Traditional | This company |
| K231003 | 2023-07-06 | GCJ | Traditional | This company |
| K221861 | 2023-02-18 | GCJ | Traditional | This company |
| K221781 | 2023-02-02 | GCJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Factory area | 15000 m² |
| Main products | Endoscopic imaging systems, 4K/HD imaging platforms, Single-use videoscopes, Flexible videoscopes |
| Certifications | Internet pharmaceutical information service certificate |
| Export markets | 30+ provinces in China |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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