Huizhou Xinyi Technology Co., Ltd.

Manufacturer and brand owner in Huizhou, Guangdong, China. 1 device type, 2 products catalogued, 2 clearances.

Registry build 21.09.26

Huizhou Xinyi Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Massager, Powered Inflatable Tube. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.

1device type
2products catalogued under its own name
2510(k) clearances

Registration

FDA registration record for Huizhou Xinyi Technology Co., Ltd.
Registered name HUIZHOU XINYI TECHNOLOGY CO., LTD
Status Registered
Registration expires 2026
Registration number 3023326918
FEI number 3023326918
DUNS 707980076
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Huizhou Xinyi Technology Co., Ltd.
Chinese legal name 惠州市信毅科技有限公司
Source Chinese medical device directory

Location

Address of Huizhou Xinyi Technology Co., Ltd.
City Huizhou
Province Guangdong
Address (Building 3), Changbu Village, Xinwei, Huiyang District
Postal code 516200
Country China

What It Makes

Device types Huizhou Xinyi Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Massager, Powered Inflatable Tube Class 2 Overlapped Compression Therapy YY-A02-B, Air compression leg massager YY-A01L, Anaconda Fightwear Air compression leg massager YY-A01L, Medisana Air compression leg massager YY-A01L 2023 37

Own-Brand Listings

Devices catalogued by Huizhou Xinyi Technology Co., Ltd.
Product Code Catalogue numbers
Homedics IRP 4
Motion Space IRP 2

Clearances

510(k) clearances naming Huizhou Xinyi Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K240981 2024-08-02 IRP Traditional This company
K221862 2022-12-08 IRP Traditional This company

From the Company

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

Information published by Huizhou Xinyi Technology Co., Ltd.
Factory area 1500 square meters
Main products Oil mist collector, Smoke cleaner, Oil-water separator, Vacuum oil purifier
Certifications ISO9001, CE

Nearby Manufacturers

Other registered manufacturers in the same city
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Double Care Medical Technology Co., Ltd. 19
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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.

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