Hebei Xinle SCI&Tech Co., Ltd.

Manufacturer and brand owner in Shijiazhuang, Hebei, China. 1 device type, 1 product catalogued, 1 clearance.

Registry build 21.09.26

Hebei Xinle SCI&Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.

1device type
1product
1510(k) clearance

Registration

FDA registration record for Hebei Xinle SCI&Tech Co., Ltd.
Registered name HEBEI XINLE SCI&TECH CO.,LTD
Status Registered
Registration expires 2026
Registration number 3014498762
FEI number 3014498762
DUNS 529813593
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Hebei Xinle SCI&Tech Co., Ltd.
Chinese legal name 河北鑫乐医疗器械科技股份有限公司
Source Qianzhan company data

Location

Address of Hebei Xinle SCI&Tech Co., Ltd.
City Shijiazhuang
Province Hebei
Address No. 2, Xingye Street, Xinle City
Postal code 050700
Country China

What It Makes

Device types Hebei Xinle SCI&Tech Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Class 2 VivaGuard SAFETY LANCETS, XL-B 21G, XL-B 28G, XL-B 30G, XL-C 21G, XL-C 28G, XL-C 30G, XL-E 21G, XL-E 28G, XL-E 30G, Lancet 2023 36

Own-Brand Listings

Devices catalogued by Hebei Xinle SCI&Tech Co., Ltd.
Product Code Catalogue numbers
xinle FMK 24

Clearances

510(k) clearances naming Hebei Xinle SCI&Tech Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K221839 2022-09-19 FMK Traditional This company

From the Company

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

Information published by Hebei Xinle SCI&Tech Co., Ltd.
Founded 2005
Main products Blood collection products, Venous collection tubes, Capillary lancets
Export markets 40+ countries

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