Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009107690

FEI Number

3009107690

Entity Name

Medwell Technology Limited

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

2nd Floor, 5th Building No. 136 Gangjian Road, Changping Town, Dongguan City Guangdong 523570, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medwell Technology Limited (Owner Number: 10041301)

Owner / Operator Contact Address

2nd Floor, 5th Building No. 136 Gangjian Road, Changping Town, Dongguan City, CN-GD 523570, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Breathing circuit Polycarbonate Syringe Saphenous Vein Distention System, irrigation beveled and blunt cannula, sterile and nonsterile

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	2015-11-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-07-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-11-18

Official Correspondent

Andy Song

US Agent Details

Amy Orrell Business: Mazza Healthcare, LLC Email: aorrell@mazzahealthcare.com Phone: (847) 2823444

Related Public Records

Same Entity

Medwell Technology Limited

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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

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

Similar Registrations

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9616445	VADI Medical Technology Co., Ltd.	Taoyuan City, TW
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3038562397	Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009107690. Last updated year: 2026. Please use registration number 3009107690 when referencing this establishment in official correspondence.