Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006984712

FEI Number

3006984712

Entity Name

HENAN TUOREN MEDICAL DEVICE CO., LTD.

City/State/Country

Changyuan Henan, CN

Establishment Address

Weiyuan Industrial Zone, Menggang, Changyuan, 453400 Henan, CHINA, Middle of Weft 7 Road, Nanpu District, Changyuan, 453400 Henan, CHINA, Changyuan Henan 453400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Henan Tuoren Medical Device Co., Ltd. (Owner Number: 10025262)

Owner / Operator Contact Address

Weiyuan Industrial Zone, Menggang, Middle of Weft 7 Road, Nanpu District, Xinxiang, CN-HA 453400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tuoren Double-lumen Endotracheal Tube 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) Medical Laryngeal Mask Airway (Model: 1#,1.5#,2#, 2.5#, 3#, 4#, 5#) Anesthetic Mask(Bending edge model: 0#,1#,2#,3#,4#,5#; Detachable model: 3#,4#,5#; Inflatalbe model:0#,1#,2#,3#,4#,5#) Breathing Circuit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2016-06-13
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2008-03-28
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2008-03-28
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2008-03-28

Official Correspondent

GuoSheng Wang

US Agent Details

Stephen Lieberman Business: Global quality consultants Email: liebs4545@gmail.com Phone: (561) 3020777

Related Public Records

Same Entity

Henan Tuoren Medical Device Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071694	Daiken Medical Co, Ltd.	COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX	2008-03-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006984712. Last updated year: 2026. Please use registration number 3006984712 when referencing this establishment in official correspondence.