Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012783431

FEI Number

3012783431

Entity Name

TONGLU QIANYAN MEDTECH CO.,LTD

City/State/Country

hangzhou Zhejiang, CN

Establishment Address

Room 101, Building 6, Medical Device Industry Park, No. 1688, Chunjiang East Road, Fengchuan Street, Tonglu County,, hangzhou Zhejiang 311501, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TONGLU QIANYAN MEDTECH CO.,LTD (Owner Number: 10051702)

Owner / Operator Contact Address

ROOM 101, BUILDING 6, MEDICAL DEVICE INDUSTRY PARK, NO. 1688, CHUNJIANG EAST ROAD, FENGCHUAN STREET, TONGLU COUNTY,, HANGZHOU, CN-ZJ 311501, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

McCartney Tube ColpotomizOR Tube ColpotomizOR Tube System Uterine ElevatOR Pro LapPakOR Liquid Scope HelpOR Liquid Scope HelpOR II Liquid Scope WarmOR Liquid Scope WarmOR Cannula DUMI ManipulatOR Uterine ElevatOR Pro Uterine PositionOR Uterine ElevatOR Pro with OccludOR Balloon Uterine ElevatOR PRO with Long Handle Uterine PositionOR PRO DUMI ManipulatOR Uterine ElevatOR Pro with OccludOR Balloon Uterine PositionOR Uterine PositionOR PRO Occluder Balloon Uterine ElevatOR PRO with Long Handle Uterine ElevatOR Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2018-09-05
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2016-12-20
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-03-10
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2019-06-23
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-08-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-04-22
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2022-01-10
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2016-12-20
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2022-04-06

Official Correspondent

EASON YIN

US Agent Details

William COY Business: Velocity Orthopedics Email: bill.coy@velocityortho.com Phone: (909) 9874343

Related Public Records

Same Entity

TONGLU QIANYAN MEDTECH 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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2032098	Isomedix Operations, Inc	ONTARIO, CA, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
2027111	APPLIED MEDICAL RESOURCES CORP.	RSM, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012783431. Last updated year: 2026. Please use registration number 3012783431 when referencing this establishment in official correspondence.