Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021610866

FEI Number

3021610866

Entity Name

Suzhou Acuvu Medical Technology Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

B1-212, Bio-Nano Park, 218 Xinghu St. Suzhou Industrial Park, Suzhou Jiangsu 215125, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Process Control Services (Owner Number: 10083910)

Owner / Operator Contact Address

5 Oak Forest Court, Portola Valley, CA 94028, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Hysteroscope accessory Disposable Hysteroscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-03-07
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-03-07

Official Correspondent

Sam Mostafavi

US Agent Details

Sam Mostafavi Business: Process Control Services Email: ipcs11@ymail.com Phone: (650) 6706972

Related Public Records

Same Entity

Process Control Services

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023365313	Acuvu Medical System Inc,	Los Altos, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Similar Registrations

Registration Number	Establishment Name	Location
3016544015	ARCULANT, INC.	Santa Clara, CA, US
1055890	PRINCETON MEDICAL GROUP, INC.	Franklin, TN, US
3004371426	Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, DE
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3003675041	SURGICAL INSTRUMENTS BELGIUM SA	GEMBLOUX Namur, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021610866. Last updated year: 2026. Please use registration number 3021610866 when referencing this establishment in official correspondence.