Data / Medical devices / China / Robotrak Technologies Co., Ltd.

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

Name: Robotrak Technologies Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Checked October 27, 2026. Source: openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files).

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.

Watch for recalls Get the full maker record

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
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)

The full lists. FDA registered medical device manufacturers in China: 4,796 rows, $127.96, or the new rows each week for $19 a month. FDA registered medical device manufacturers and other establishments: 25,781 rows, $337.81, or the new rows each week for $19 a month. 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. For agents and scripts: every list with its row count and price is at https://specstream.ai/data/lists.json.

Get the first 200 rows free

Devices it lists

Device	Product code	Class	Role	Source
Ophthalmoscope, Ac-Powered	HLI	2	Manufacturer	accessdata.fda.gov
Ophthalmoscope, Laser, Scanning	MYC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

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

More device makers in China

Compare with other manufacturers

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. Spot a wrong value? Write to [email protected] with the link to this page.

$10 of credit on sign-up, no card.