Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010455511

FEI Number

3010455511

Entity Name

Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building 13, No. 122 Yongan Road, Xushuguan Town, New District, Suzhou Jiangsu 215151, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Thermo Fisher Scientific (Owner Number: 2517925)

Owner / Operator Contact Address

168 Third Avenue, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ST 8 Centrifuge (75007200) Megafuge 8 Centrifuge (75007210) Thermo Scientific C1T IVD-MD, 220-230V(75008005) Fisher Scientific accuSpin 24C (75007240) SL 8 Centrifuge (75007220)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	1992-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Marilyn Barry Email: marilyn.barry@thermofisher.com Phone: (828) 6584400

Related Public Records

Same Entity

Thermo Fisher Scientific

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006190736	LABOMEX MBP	TIJUANA Baja California, MX
2517925	FISHER SCIENTIFIC COMPANY L.L.C.	PITTSBURGH, PA, US
3006440892	OXOID AUSTRALIA PTY LIMITED	THEBARTON South Australia, AU
1314344	Nalge Nunc International Corporation	Rochester, NY, US
3003150158	NUNC A/S	ROSKILDE Sjalland, DK

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2008	Thermo Fisher Scientific	1	Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

Similar Registrations

Registration Number	Establishment Name	Location
3010394461	HERMLE LABORTECHNIK GMBH	Wehingen Baden-Wurttemberg, DE
3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3033848228	JOAN LAB EQUIPMENT (ZHEJIANG) CO.,LTD.	Huzhou Zhejiang, CN
3004142400	GLOBUS MEDICAL, INC.	AUDUBON, PA, US
3017155466	KIT COMPANY	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010455511. Last updated year: 2026. Please use registration number 3010455511 when referencing this establishment in official correspondence.