Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004468256

FEI Number

3004468256

Entity Name

SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.

City/State/Country

Suzhou City Jiangsu, CN

Establishment Address

Beiqiao Town, Suzhou City Jiangsu 215144, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Suzhou KYUAN Medical Apparatus Co., Ltd. (Owner Number: 10077840)

Owner / Operator Contact Address

Beiqiao Town, Suzhou City, CN-JS 215144, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Safety Lancets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-10-31
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-11-08
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-03-07

Official Correspondent

Shi Ye

US Agent Details

Adeline Yi Business: MediPurpose Inc Email: adelineyi@medipurpose.com Phone: (404) 8553655

Related Public Records

Same Entity

Suzhou KYUAN Medical Apparatus 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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3004525100	SOYAGREENTEC CO.,LTD	Hwaseong-si Gyeonggi, KR
3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN
3012172036	TASSO INC	Seattle, WA, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL
3007384659	SIMPLE DIAGNOSTICS	Maspeth, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004468256. Last updated year: 2026. Please use registration number 3004468256 when referencing this establishment in official correspondence.