Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014611142

FEI Number

3014611142

Entity Name

TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO LTD

City/State/Country

Tianjin, CN

Establishment Address

A02, Plant B, No. 278, Hangkong Road,, Tianjin Free Trade Zone(Air Port Industrial Park),, Tianjin 300308, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tianjin UWell Medical Device Manufacturing Co.,Ltd (Owner Number: 10057781)

Owner / Operator Contact Address

A02, Plant B, No. 278, Hangkong Road,, Tianjin Free Trade Zone(Air Port Industrial Park),, Tianjin, CN-TJ 300308, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162387

PMA Number

N/A

All Registered Proprietary Names

U-Well U-Well

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2018-05-24
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2018-05-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-05-24

Official Correspondent

Ningning Wang

US Agent Details

Qian Li Business: CARELIFE USA INC Email: Li@Carelifeusa.Com Phone: (404) 6612228

Related Public Records

Same Entity

Tianjin UWell Medical Device Manufacturing 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
K904849	Origin Medsystems, Inc.	ORIGINEEDLE(TM)	1991-03-29
K981334	Richard Wolf Medical Instruments Corp.	LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)	1998-09-10
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014611142. Last updated year: 2026. Please use registration number 3014611142 when referencing this establishment in official correspondence.