Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010198939

FEI Number

3010198939

Entity Name

TIANJIN VANFORM HIGH ENERGY PHYSICS TECHNOLOGY CO., LTD.

City/State/Country

Tianjin, CN

Establishment Address

Teda Wit Valley, Binhai New District, Tianjin 300480, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Tianjin Vanform High Energy Physics Technology Co., Ltd. (Owner Number: 10043361)

Owner / Operator Contact Address

Teda Wit Valley, Binhai New District, Tianjin, CN-TJ 300480, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

APPARATUS, SUCTION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2013-02-08

Official Correspondent

Charles Shen

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Tianjin Vanform High Energy Physics Technology 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number	Establishment Name	Location
3017101761	IC SURGICAL INC	Grand Rapids, MI, US
3013025177	Phillips-Medisize Healthcare (Suzhou) CO., LTD	Suzhou Jiangsu, CN
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
3026986849	FANSHENG TECHNOLOGY (GUANGDONG) CO., LTD .	Zhongshan City Guangdong, CN
3013188547	ORTA MEDICAL LTD	TZUR YIGAL Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010198939. Last updated year: 2026. Please use registration number 3010198939 when referencing this establishment in official correspondence.