Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005347827

FEI Number

3005347827

Entity Name

GENTEC (SHANGHAI) CORPORATION

City/State/Country

SHANGHAI, CN

Establishment Address

NO. 499 WENJI ROAD, SONGJIANG DISTRICT, SHANGHAI 201616, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

GENTEC (SHANGHAI) CORPORATION (Owner Number: 9077543)

Owner / Operator Contact Address

NO.499 WENJI ROAD,, SONGJIANG DISTRICT, SHANGHAI, CN-NOTA 201616, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Breathing Circuit SUCTION REGULATOR; VACUUM REGULATOR Face Mask MEDICAL AIR/OXYGEN BLENDER High Flow Nasal Cannula (HFNC) FLOW GAUGE; NONBACK-PRESSURE COMPENSATED FLOWMETER GAS PRESSURE GAUGE BACK-PRESSURE COMPENSATED FLOWMETER GENTEC GAS PRESSURE REGULATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2020-03-30
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2005-09-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-20
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2016-12-08
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-03-20
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	2005-09-14
BXH	Gauge, Gas Pressure, Cylinder/Pipeline	Anesthesiology	Class 1	868.2610	2005-09-14
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2005-09-14
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2005-09-14

Official Correspondent

JAMES KUO

US Agent Details

JIM TSO Business: GENSTAR TECHNOLOGIES CO., INC. Email: jim@genstartech.com Phone: (909) 6062726

Related Public Records

Same Entity

GENTEC (SHANGHAI) CORPORATION

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005347827. Last updated year: 2026. Please use registration number 3005347827 when referencing this establishment in official correspondence.