Arrow Medsource Group Limited

Manufacturer and brand owner in Hongkong, China. 17 device types, 8 products catalogued.

Registry build 21.09.26

Arrow Medsource Group Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Mask, Surgical and 15 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.

17device types registered with the FDA
8products catalogued under its own name

Registration

FDA registration record for Arrow Medsource Group Limited
Registered name ARROW MEDSOURCE GROUP LIMITED
Status Registered
Registration expires 2026
Registration number 3016685880
FEI number 3016685880
DUNS 686378503
Establishment type Contract manufacturer, Specification developer, Manufacturer, Exporter

Location

Address of Arrow Medsource Group Limited
City Hongkong
Address FLAT 10, 3/F WAH YIU INDUS
Postal code 999077
Country China

What It Makes

Device types Arrow Medsource Group Limited is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 2020 439
Cap, Surgical Class 1 Bouffant Cap 2020 178
Catheter And Tip, Suction Class 2 Catheter And Tip, Suction 2024 70
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Class N General Face Mask 2020 182
Gown, Examination Class 1 Gown Examination 2020 109
Mask, Surgical Class 2 2020 125
Medical Glove, Specialty Class 1 Polymer Patient Examination Glove 2021 48
Needle, Hypodermic, Single Lumen Class 2 AMG 2021 71
Non-Surgical Gown Class 1 Isolation Gown, Chemo Gown; Coverall with tape; Coverall w/o tape; Disposable Coverall; Disposable Isolation Gown 2020 318
Polymer Patient Examination Glove Class 1 Polymer Patient Examination Glove 2020 83
Respirator, Surgical Class 2 2020 118
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Class 1 Ophthalmic Eye Shield 2020 384
Shoe And Shoe Cover, Conductive Class 1 Disposable Shoe Covers 2020 32
Syringe, Antistick Class 2 AMG 2021 39
Syringe, Piston Class 2 AMG 2021 60
Tubing, Noninvasive Class 2 Tubing, Noninvasive 2024 33
Tubing, Pressure And Accessories Class 1 2024 45

Own-Brand Listings

Devices catalogued by Arrow Medsource Group Limited
Product Code Catalogue numbers
AMG LYU 22
AMG LZA 16
AMG OEA 8
AMG FMI 6
AMG FYF 3
AMG BWP 3
AMG HOY 1
AMG MSH 1

Clearances

No clearance names Arrow Medsource Group Limited as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Arrow Medsource Group Limited or its listings
Clearance Decision date Product code Route Held by
K193526 2020-07-17 FMF Traditional Jiangsu Caina Medical Co., Ltd.
K162923 2017-02-06 LZA Traditional Hartalega NGC SDN BHD
K123787 2013-07-17 FXX Traditional Jingzhou Haixin Green Cross Medical Products Co.,L
K091652 2009-09-04 LZA Traditional Hartalega SDN BHD
K020474 2002-07-23 MSH Traditional Makrite Industries, Inc.
K003985 2001-02-09 LZA Traditional Guthrie Medicare Products (Melaka) Sdn Bhd

Nearby Manufacturers

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