Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007699074

FEI Number

3007699074

Entity Name

Sartorius Stedim Lab Ltd.

City/State/Country

Stonehouse Gloucestershire, GB

Establishment Address

Sperry Way, Stonehouse Park, Stonehouse Gloucestershire GL10 3UT, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Sartorius Stedim North America Inc./Sartorius Corporation (Owner Number: 9005426)

Owner / Operator Contact Address

545-1 Johnson Ave, Bohemia, NY 11716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vivafree 2 30K (VFR02H22,VFR02H23) Vivaspin 20 (VS2002IVD) Vivafree 500 125K (VFR01H82,VFR01H83) Vivaspin 4 10K (VS0404, VS0405) Vivaspin 4 Turbo (VS04T02IVD) Vivaspin 6 (VS0602IVD) Vivafree 500 30K (VFR01H22,VFR01H23) Vivaspin 6 (VS0603VP)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2016-05-05

Official Correspondent

Terri Brooks

US Agent Details

Terri Brooks Business: Sartorius Stedim North America Inc. Email: Terri.brooks@sartorius.com Phone: (631) 4699877

Related Public Records

Same Entity

Sartorius Stedim North America Inc./Sartorius Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010127792	Sartorius Liquid Handling Oy	Kajaani, Finland Kainuu, FI

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007699074. Last updated year: 2026. Please use registration number 3007699074 when referencing this establishment in official correspondence.