Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017171460

FEI Number

3017171460

Entity Name

MEDTECS INTERNATIONAL CORPORATION LIMITED

City/State/Country

City of Hamilton, BM

Establishment Address

Clarendon House, 2 Church Street, City of Hamilton HM11, BM

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MEDTECS (CAMBODIA) CORP. LIMITED (Owner Number: 10074525)

Owner / Operator Contact Address

National road number 7, Phum Ampil Leu, Khum Ampil, Srok Kampong Siem, KH-3 030501, KH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102692

PMA Number

N/A

All Registered Proprietary Names

Mattress Pad Mattress Cover (Medical purpose)-STRETCHER SHEETS shoes covers Operating-Room Shoe Cover UNDERCAST PADDING Flat/Fitted Sheets Operating Room Towel Pillowcases Disposable Medical Mask Disposable Medical Mask (Non-sterile) Face Shield Medical Goggles Gloves (Disposable Rubber Gloves) Medical Face Shield Protective Mask Cuff Barrier Sleeve Surgical Masks Isolation Gown Disposable Isolation Gown Coverall with tape Disposable Coverall Chemo Gown AMD-Ritmed AssureWear Versagown Conductive Shoe and Shoe Cover Surgical Gowns

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-05-26
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-05-26
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2020-05-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-05-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-03-06
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-08-16
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-05-26
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-05-26
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-07-31

Official Correspondent

No official correspondent registered.

US Agent Details

ESTHER LIU Email: fda@jinservices.com Phone: (404) 9323207

Related Public Records

Same Entity

MEDTECS (CAMBODIA) CORP. LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003561450	HANGZHOU JINCHENG MEDICAL SUPPLIES MANUFACTURE CO., LTD.	Hangzhou Zhejiang, CN
3012344767	MEDTECS (CAMBODIA) CORP. LIMITED	Srok Kampong Siem Kampong Cham, KH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017171460. Last updated year: 2026. Please use registration number 3017171460 when referencing this establishment in official correspondence.