Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017961114

FEI Number

3017961114

Entity Name

SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

766 Nanxiang Rd. Jiangling Sub-district, Wujiang District,, Suzhou Jiangsu 215200, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Suzhou ProSteri Medical Technology Co., Ltd. (Owner Number: 10079556)

Owner / Operator Contact Address

766 Nanxiang Rd. Jiangling Sub-district, Wujiang District,, Suzhou, CN-JS 215200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tray, catheterization Tubes, gastrointestinal SYRINGE, IRRIGATING (NON DENTAL) SpeediCath Flex Set with Accessories Firefighter NC Pro PTCA Balloon Catheter Numen Coil Embolization System NumenFR Detachment System Tray, catheterization Set, administration, intravascular urological irrigation system Wire, guide, catheterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCYTRANSDUCER, PRESSURE, CATHETER TIP Numen Coil Embolization System NumenFR Detachment System CATHETER AND TIP, SUCTION TRAP, STERILE SPECIMEN CONTAINER, SPECIMEN TUBE, ASPIRATING Firefighter Pro PTCA Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2020-12-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-12-11
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2020-12-11
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2025-09-09
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2024-11-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2024-05-14
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-05-14
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2021-05-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-12-11
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2020-12-11
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2020-12-11
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2020-12-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-12-11
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-11-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2024-11-13
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2020-12-11
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2020-12-11
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2021-05-20
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2020-12-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2026-06-08

Official Correspondent

Charles Shen

US Agent Details

Charles Shen Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Suzhou ProSteri Medical 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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

Similar Registrations

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3005669815	AMSINO MEDICAL (KUNSHAN) CO., LTD.	KUNSHAN CITY Jiangsu, CN
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3006082230	C.R. BARD, INC.	MADISON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017961114. Last updated year: 2026. Please use registration number 3017961114 when referencing this establishment in official correspondence.