Henan Tuoren Medical Device Co., Ltd.

Manufacturer and brand owner in Changyuan, Henan, China. 5 device types, 4 products catalogued, 1 clearance.

Registry build 21.09.26

Henan Tuoren Medical Device Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Gas, Anesthetic, Airway, Oropharyngeal, Anesthesiology and 3 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.

5device types registered with the FDA
4products catalogued under its own name
1510(k) clearance

Registration

FDA registration record for Henan Tuoren Medical Device Co., Ltd.
Registered name HENAN TUOREN MEDICAL DEVICE CO., LTD.
Status Registered
Registration expires 2026
Registration number 3006984712
FEI number 3006984712
DUNS 526982680
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Henan Tuoren Medical Device Co., Ltd.
Chinese legal name 河南驼人医疗器械集团有限公司
Unified social credit code 914107281734449880
Source NMPA UDI database

Location

Address of Henan Tuoren Medical Device Co., Ltd.
City Changyuan
Province Henan
Address Weiyuan Industrial Zone, Menggang, Changyuan, 453400 Henan, CHINA
Postal code 453400
Country China

What It Makes

Device types Henan Tuoren Medical Device Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Airway, Oropharyngeal, Anesthesiology Class 1 Medical Laryngeal Mask Airway (Model: 1#,1.5#,2#, 2.5#, 3#, 4#, 5#), Blockbuster Laryngeal Mask Airway (Model: 1#,1.5#,2#, 2.5#, 3#, 4#, 5#), Oropharyngeal airway (Model: 4#, 5#, 6#, 7#, 8#, 9#, 10#, 11#, 12#, 3cm~12cm) 2008 84
Circuit, Breathing (W Connector, Adaptor, Y Piece) Class 1 Breathing Circuit 2008 55
Condenser, Heat And Moisture (Artificial Nose) Class 1 Heat and Moisture Exchanger (Specifications: Adult/Child/infant/Tracheotomy) 2014 29
Mask, Gas, Anesthetic Class 1 Anesthetic Mask(Bending edge model: 0#,1#,2#,3#,4#,5#; Detachable model: 3#,4#,5#; Inflatalbe model:0#,1#,2#,3#,4#,5#) 2008 71
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class 2 Tuoren Double-lumen Endotracheal Tube 2016 4

Own-Brand Listings

Devices catalogued by Henan Tuoren Medical Device Co., Ltd.
Product Code Catalogue numbers
Airway, Oropharyngeal, Anesthesiology CAE 21
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI 18
Mask, Gas, Anesthetic BSJ 15
Condenser, Heat And Moisture (Artificial Nose) BYD 4

Clearances

510(k) clearances naming Henan Tuoren Medical Device Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K152251 2016-06-10 CBI Traditional This company

From the Company

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

Information published by Henan Tuoren Medical Device Co., Ltd.
Founded 1993
Employees 10000+
Main products Disposable medical devices, Infusion devices, Catheters, Anesthesia supplies, Nursing consumables

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