# Robotrak Technologies Co., Ltd.: FDA-registered device maker

Checked October 27, 2026.

Robotrak Technologies Co., Ltd. is registered with the FDA (registration 3043126966) in Nanjing Jiangsu, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2026. Registered through 2027. FDA data exported November 9, 2026.

Source from Robotrak Technologies Co., Ltd. knowing what the FDA has cleared, any recalls and who to call about orders. $10 of credit on sign-up, no card.

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## The full lists

This record is a row of these lists. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (establishment name, FEI number, street, city, state, postal code and 12 more), which open on your screen as soon as the payment clears and come by email.

- [FDA registered medical device manufacturers in China](https://specstream.ai/data/medical-devices/country/china): 4,796 rows, establishments with an active FDA registration in the FDA files exported November 9, 2026, $127.96, or the new rows each week for $19 a month. Buy: https://specstream.ai/data/medical-devices/country/china
- [FDA registered medical device manufacturers and other establishments](https://specstream.ai/data/medical-devices): 25,781 rows, establishments with an active FDA registration in the FDA files exported November 9, 2026, $337.81, or the new rows each week for $19 a month. Buy: https://specstream.ai/data/medical-devices

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the manufacturers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

- FDA registration number: [3043126966](https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223043126966%22&limit=1)
- Address: 1F, Building 2, No.6 Qiande Rd, Jiangning District, Nanjing Jiangsu, China, 210000
- Owner or operator: Robotrak Technologies Co., Ltd. (10094717)
- Roles: Complaint file establishment, Manufacturer
- First device listed: December 18, 2025
- Registered through: 2027
- Brand names listed: Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)

## Devices it lists

| Device | Product code | Class | Role | Source |
| --- | --- | --- | --- | --- |
| [Ophthalmoscope, Ac-Powered](https://specstream.ai/data/medical-devices/device/ophthalmoscope-ac-powered-hli) | HLI | 2 | Manufacturer | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?search=HLI) |
| [Ophthalmoscope, Laser, Scanning](https://specstream.ai/data/medical-devices/device/ophthalmoscope-laser-scanning-myc) | MYC | 2 | Complaint file establishment, Manufacturer | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?search=MYC) |

## 510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
| --- | --- | --- | --- | --- | --- | --- |
| October 27, 2026 | K261740 | Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV) | MYC | Substantially Equivalent | Robotrak Technologies Co., Ltd. | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261740) |

## More in Nanjing Jiangsu

- [Micro-Tech (Nanjing) Co., Ltd.](https://specstream.ai/data/medical-devices/maker/micro-tech-nanjing-co-ltd-3013440400)
- [LG Electronics Nanjing New Technology Co., Ltd.](https://specstream.ai/data/medical-devices/maker/lg-electronics-nanjing-new-technology-co-ltd-3004434200)
- [Nanjing Anjian Medical Device Co.,ltd.](https://specstream.ai/data/medical-devices/maker/nanjing-anjian-medical-device-co-ltd-3015142802)
- [Nanjing Jusha Display Technology Co., Ltd](https://specstream.ai/data/medical-devices/maker/nanjing-jusha-display-technology-co-ltd-3010043098)
- [Nanjing Bestview Laser S&T Co.,ltd.](https://specstream.ai/data/medical-devices/maker/nanjing-bestview-laser-s-t-co-ltd-3021011208)
- [Canyon Medical Inc.](https://specstream.ai/data/medical-devices/maker/canyon-medical-inc-3016688836)
- [Nanjing Topwin Co., Ltd.](https://specstream.ai/data/medical-devices/maker/nanjing-topwin-co-ltd-3030171742)
- [Augment Intelligent Medical System (china) Co., Ltd.](https://specstream.ai/data/medical-devices/maker/augment-intelligent-medical-system-china-co-ltd-3026309987)
- [Clinisupplies (nanjing) Co., Ltd](https://specstream.ai/data/medical-devices/maker/clinisupplies-nanjing-co-ltd-3014195785)
- [ECO Medical Technology (Nanjing) Co., Ltd.](https://specstream.ai/data/medical-devices/maker/eco-medical-technology-nanjing-co-ltd-3020309549)

## More device makers in China

- [Zimmer (Shanghai) Medical International Trading Co., Ltd.](https://specstream.ai/data/medical-devices/maker/zimmer-shanghai-medical-international-trading-co-ltd-3015207155)
- [Shenzhen Mindray Bio-Medical Electronics Co.,LTD](https://specstream.ai/data/medical-devices/maker/shenzhen-mindray-bio-medical-electronics-co-ltd-3007603826)
- [Ge Medical Systems (china) Co., Ltd.](https://specstream.ai/data/medical-devices/maker/ge-medical-systems-china-co-ltd-9710602)
- [Shenzhen Mindray Bio-Medical Electronics Co., Ltd.](https://specstream.ai/data/medical-devices/maker/shenzhen-mindray-bio-medical-electronics-co-ltd-3009156722)
- [Arthrex (Shanghai) Co., Ltd.](https://specstream.ai/data/medical-devices/maker/arthrex-shanghai-co-ltd-3014262693)

## Compare with other manufacturers

- [All manufacturers of scanning laser ophthalmoscopes](https://specstream.ai/data/medical-devices/device/ophthalmoscope-laser-scanning-myc)
- [All manufacturers of AC-powered ophthalmoscopes](https://specstream.ai/data/medical-devices/device/ophthalmoscope-ac-powered-hli)

Source: [openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files)](https://open.fda.gov/data/downloads/). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. FDA registration lists an establishment with the FDA and is not an approval of it: a 510(k) clearance or a PMA approval is for one device.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).