Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027605735

FEI Number

3027605735

Entity Name

embecta Medical Devices (Suzhou) Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.1 Liangpu Street, Suzhou Industrial Park, Suzhou Jiangsu --, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

embecta Corp. (Owner Number: 10084714)

Owner / Operator Contact Address

300 Kimball Drive, Parsippany, NJ 07054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213478

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-10-19

Official Correspondent

Heather Reed

US Agent Details

Heather Reed Business: EMBECTA CORP. Email: regulatory.affairs@embecta.com Phone: (978) 3874086

Related Public Records

Same Entity

embecta Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3024508819	embecta medical I LLC	Holdrege, NE, US
3023359743	embecta Penel Limited	Dun Laoghaire Co. Dublin, IE
3022699058	Embecta Medical II LLC	Parsippany, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027605735. Last updated year: 2026. Please use registration number 3027605735 when referencing this establishment in official correspondence.