Data / Medical devices / Bermuda / Medtecs International Corporation Limited

Medtecs International Corporation Limited: FDA-registered device maker in City of Hamilton Hamilton(Parish), Bermuda, 5 510(k) clearances

Name: Medtecs International Corporation Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtecs International Corporation Limited is registered with the FDA (registration 3017171460) in City of Hamilton Hamilton(Parish), Bermuda. It lists 19 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 4, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017171460
Address: Clarendon House, 2 Church Street, City of Hamilton Hamilton(Parish), Bermuda, HM11
Owner or operator: MEDTECS (CAMBODIA) CORP. LIMITED (10074525)
Roles: Exporter to the US
First device listed: May 26, 2020
Registered through: 2026
Brand names listed: AMD-Ritmed AssureWear Versagown, ASTM PB70 Level 4 Isolation Gown, Bandage, Bouffant Cap, Chemo Gown, Conductive Shoe and Shoe Cover, Coverall with tape, Cuff Barrier Sleeve and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Exporter to the US	accessdata.fda.gov
Bandage, Elastic	FQM	1	Exporter to the US	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US	accessdata.fda.gov
Cap, Surgical	FYF	1	Exporter to the US	accessdata.fda.gov
Component, Cast	LGF	1	Exporter to the US	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Exporter to the US	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Exporter to the US	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Exporter to the US	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Exporter to the US	accessdata.fda.gov
Gown, Examination	FME	1	Exporter to the US	accessdata.fda.gov
Gown, Isolation, Surgical	FYC	2	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Exporter to the US	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Exporter to the US	accessdata.fda.gov
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs	QSO	2	Exporter to the US	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Exporter to the US	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US	accessdata.fda.gov
Shoe And Shoe Cover, Conductive	BWP	1	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 4, 2023	K222907	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	LZA	Substantially Equivalent	Rmkh Glove (Cambodia) Co., Ltd.	accessdata.fda.gov
October 21, 2022	K210414	CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown	FYC	Substantially Equivalent	Medtecs (Taiwan) Corp.	accessdata.fda.gov
March 2, 2022	K203376	ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G	FXX	Substantially Equivalent	Medtecs (Taiwan) Corp.	accessdata.fda.gov
January 17, 2020	K190306	AMD Ritmed AssureWear VersaGown	FYC	Substantially Equivalent	Amd Medicom, Inc.	accessdata.fda.gov
March 11, 2011	K102692	SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO	FYA	Substantially Equivalent	Hangzhou Jincheng Medical Supplier Manufacture Co.	accessdata.fda.gov

Compare with other makers

Updated January 4, 2023. 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.