Guangzhou T.K Medical Instrument Co., Ltd.

Manufacturer and brand owner in Guangzhou, Guangdong, China. 7 device types, 2 products catalogued, 2 clearances.

Registry build 21.09.26

Guangzhou T.K Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Thoracic, Pneumoperitoneum Needle and 5 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.

7device types registered with the FDA
2products catalogued under its own name
2510(k) clearances

Registration

FDA registration record for Guangzhou T.K Medical Instrument Co., Ltd.
Registered name GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
Status Registered
Registration expires 2026
Registration number 3008191256
FEI number 3008191256
DUNS 546374737
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Guangzhou T.K Medical Instrument Co., Ltd.
Chinese legal name 广州迪克医疗器械有限公司
Unified social credit code 9144011675940764XQ
Source export sales certificate, Guangdong medical products administration

Location

Address of Guangzhou T.K Medical Instrument Co., Ltd.
City Guangzhou
Province Guangdong
Address No. 7, Jianye Six Road, East Zone of Guangzhou Economic and Technological Development District,
Postal code 510765
Country China

What It Makes

Device types Guangzhou T.K Medical Instrument Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Camera, Television, Endoscopic, Without Audio Class 1 GTK Endoscope Camera System 2025 6
Insufflator, Laparoscopic Class 2 Medline Pneumoperitoneum Needle, GTK Veress Needles 2012 10
Laparoscope, General & Plastic Surgery Class 2 GTK Trocars 2024 46
Orthosis, Thoracic Class 1 GTK Vacuum Bells 2024 30
Pneumoperitoneum Needle Class 2 Medline Pneumoperitoneum Needle, GTK Veress Needles 2012 4
Ring (Wound Protector), Drape Retention, Internal Class 2 GTK Wound Protectors/Retractors 2025 3
Source, Carrier, Fiberoptic Light Class 1 GTK Endolight Source 2025 6

Own-Brand Listings

Devices catalogued by Guangzhou T.K Medical Instrument Co., Ltd.
Product Code Catalogue numbers
GTK Trocars GCJ 12
GTK HIF 2

Clearances

510(k) clearances naming Guangzhou T.K Medical Instrument Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K193272 2020-07-09 GCJ Traditional This company
K193339 2020-01-30 HIF Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Guangzhou T.K Medical Instrument Co., Ltd.
Main products minimally invasive surgical instruments, sleep surgery devices, laparoscopic instruments
Certifications ISO 13485:2016, GMP NMPA, US FDA Factory Registration

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
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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.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer