What does Jiaxing Xinyi Medical Instrument Co., Ltd. manufacture?

Registered with the FDA for 12 device types.

Is Jiaxing Xinyi Medical Instrument Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

Jiaxing Xinyi Medical Instrument Co., Ltd. → Supplier → Allomedo

Jiaxing Xinyi Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cane, Crutch and 10 other device types. Its earliest product listing with the FDA dates from 2015.

Registration

FDA registration record for Jiaxing Xinyi Medical Instrument Co., Ltd.
Registered name	JIAXING XINYI MEDICAL INSTRUMENT CO., LTD.
Status	Registered
Registration expires	2026
Registration number	3011669224
FEI number	3011669224
Establishment type	Contract manufacturer, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Jiaxing Xinyi Medical Instrument Co., Ltd.
Chinese legal name	嘉兴信益医疗器材有限公司
Source	Baidu Baike

Location

Address of Jiaxing Xinyi Medical Instrument Co., Ltd.
City	Jiashan
Province	Zhejiang
Address	No.15,Jinyi Road,(1)and No.100 Zhijiang Road,
Postal code	314100
Country	China

What It Makes

Device types Jiaxing Xinyi Medical Instrument Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Accessory, Surgical Apparel	Class 1	disposable face mask	2020	439
Adaptor, Hygiene	Class 1	aluminum commode, round shower chair, steel commode with castors, aluminum shower chair with backrest	2015	193
Bed, Manual	Class 1	manual bed	2015	122
Cane	Class 1	underarm crutch, single hand cane, polio auxiliary cane	2015	97
Crutch	Class 1	Crutch	2016	112
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Class N	disposable face mask	2020	182
Mask, Scavenging	Class 1	disposable face mask	2020	158
Non-Surgical Gown	Class 1	Protective clothing, Isolation Gown	2020	318
Table, Mechanical	Class 1	overbed table	2015	46
Tips And Pads, Cane, Crutch And Walker	Class 1	tips and pads, cane, crutch and walker	2015	69
Walker, Mechanical	Class 1	aluminum walker with castors, steel walker with castors, aluminum rollator, steel rollator	2015	183
Wheelchair, Mechanical	Class 1	Wheelchair	2018	46

Clearances

No clearance names Jiaxing Xinyi Medical Instrument Co., Ltd. as applicant. One is held by another company 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 Jiaxing Xinyi Medical Instrument Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K990463	1999-03-15	IOR	Traditional	Medline

From the Company

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

Information published by Jiaxing Xinyi Medical Instrument Co., Ltd.
Founded	2013
Employees	120+
Factory area	25000 square meters
Main products	Walkers, Rollators, Wheelchairs, Shower chairs, Medical rehabilitation equipment
Certifications	ISO 13485
Export markets	Europe, Asia, US

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer	Device types
Zhejiang Shuxiao Personal Hygiene Products Co., Ltd.	5
Cyden Medical Technology (Zhejiang) Co., Ltd.	2
Jiashan Yingjie Electron Co Ltd	1

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.

Jiaxing Xinyi Medical Instrument Co., Ltd.