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Advanced Medtech Corporate Pte Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 6 510(k) clearances

Name: Advanced Medtech Corporate Pte Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Advanced Medtech Corporate Pte Ltd is registered with the FDA (registration 3016881508) in Singapore Central Singapore, Singapore. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 31, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016881508
Address: 2 Venture Drive #23-18 Vision Exchange, Singapore Central Singapore, Singapore, 608526
Owner or operator: Advanced MedTech Corporate Pte Ltd (10073211)
Roles: Exporter to the US
First device listed: May 7, 2020
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Exporter to the US	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Exporter to the US	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Exporter to the US	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
January 31, 2025	K243820	Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250	FED	Substantially Equivalent	Dornier Medtech America	accessdata.fda.gov
November 9, 2022	K222162	Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)	FAJ	Substantially Equivalent	Shanghai AnQing Medical Instrument Co., Ltd.	accessdata.fda.gov
October 5, 2022	K222737	Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)	FGB	Substantially Equivalent	Shanghai AnQing Medical Instrument Co., Ltd.	accessdata.fda.gov
August 26, 2022	K220159	Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)	FGB	Substantially Equivalent	Shanghai AnQing Medical Instrument Co., Ltd.	accessdata.fda.gov
July 24, 2020	K201293	Ureterorenoscope System	FGB	Substantially Equivalent	Shanghai AnQing Medical Instrument Co., Ltd.	accessdata.fda.gov
July 3, 2018	K180367	Ureterorenoscope System	FGB	Substantially Equivalent	Shanghai AnQing Medical Instrument Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). 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. 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.