Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015337348

FEI Number

3015337348

Entity Name

Primecare Medical (Suzhou) Co.,Ltd.

City/State/Country

Changshu Jiangsu, CN

Establishment Address

Building A1/A4, No. 2 Zengfu Road, Guli Development Zone, 215532 Changshu City, Jiangshu Province, PEOPLE'S REPUBLIC OF CHINA, Changshu Jiangsu 215532, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Primecare Medical (Suzhou) Co.,Ltd. (Owner Number: 10059848)

Owner / Operator Contact Address

Building A1/A4, No. 2 Zengfu Road, Guli Development Zone, 215532 Changshu City, Changshu, CN-JS 215532, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Suction Yankauer Irrigation tray, Irrigation syringe, Ear Ulcer syringe Enteral Specific transition connector Medication Bottle Adaptor Trachestomy care kit Specimen container, STR Skin Staple removal Kit; Suture removal kit /tray APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED Urethral Catheterization Tray (w/ or w/o Catheter) Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab Urine collector pediatric st Speicmen Collector Urine/Stool, Non-Str; Specimen Container Foley insertion tray Catheter Care Tray Urine collector pediatric NS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-06-28
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2019-05-05
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-06-08
LRQ	Tracheostomy And Nasal Suctioning Kit	Unknown	Class 1	N/A	2019-05-05
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2022-07-26
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2019-05-05
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2024-12-03
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2020-03-24
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2023-02-27
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-02-27
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2023-02-27
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2023-02-27
EXI	Device, Paste-On For Incontinence, Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-06-28
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-04-14
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2019-05-05
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-06-28

Official Correspondent

Juan Wu

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Primecare Medical (Suzhou) 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
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
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

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
2126670	SCANLAN INTERNATIONAL, INC.	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015337348. Last updated year: 2026. Please use registration number 3015337348 when referencing this establishment in official correspondence.