Ningbo HLS Medical Products Co., Ltd.

Registered establishment in Cixi, Zhejiang, China. 7 device types, 1 clearance.

Registry build 21.09.26

Ningbo HLS Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Chest Drainage Kit, Bottle, Collection, Vacuum and 5 other device types. Its earliest product listing with the FDA dates from 2016.

7device types registered with the FDA
1510(k) clearance

Registration

FDA registration record for Ningbo HLS Medical Products Co., Ltd.
Registered name NINGBO HLS MEDICAL PRODUCTS CO., LTD.
Status Registered
Registration expires 2026
Registration number 3002732769
FEI number 3002732769
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Ningbo HLS Medical Products Co., Ltd.
Chinese legal name 宁波华莱斯医疗器械有限公司
Source export sales certificate, Zhejiang medical products administration

Location

Address of Ningbo HLS Medical Products Co., Ltd.
City Cixi
Province Zhejiang
Address No. 2277, Zhouxi Road, Zhouxiang Town
Postal code 315324
Country China

What It Makes

Device types Ningbo HLS Medical Products Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 Face Mask, Medical Face Mask 2020 439
Apparatus, Suction, Operating-Room, Wall Vacuum Powered Class 2 Suction Liner 2024 30
Applicator, Absorbent Tipped, Sterile Class 1 Disposable Sampling Swab 2020 100
Bottle, Collection, Vacuum Class 2 Suction Bag; Suction Tube 2024 88
Chest Drainage Kit Class 2 Disposable Chest Drainage Bottle 2025 2
Container, Specimen Mailer And Storage, Sterile Class 1 Sample Collection Kit 2020 33
Spatula, Cervical, Cytological Class 2 Disposable Cervical Brush, A1 2016 3

Clearances

510(k) clearances naming Ningbo HLS Medical Products Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K141057 2015-05-14 HHT Traditional This company

From the Company

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

Information published by Ningbo HLS Medical Products Co., Ltd.
Main products Disposable cervical sampling swabs, Sampling swabs, Viral sampling tubes, Cell preservation liquid, Gynecological consumables
Certifications ISO standards, CE standards
OEM and ODM Offered

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