FDA Registration
Active
🇬🇧 United Kingdom
Vivafree 2 30K (VFR02H21,VFR02H22,VFR02H23)
Reg #: 3007699074
·
FEI: 3007699074
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Sartorius Stedim Lab Ltd.
- Registration Number
- 3007699074
- FEI Number
- 3007699074
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Sperry Way, Stonehouse Park
- City
- Stonehouse Gloucestershire
- Country
- GB
Owner / Operator
- Firm Name
- Sartorius Stedim North America Inc./Sartorius Corporation
- Operator Number
- 9005426
- Address
- 545-1 Johnson Ave
- City
- Bohemia
- State
- NY
- Postal Code
- 11716
- Country
- US
- Correspondent
- Terri Brooks
US Agent
- Business Name
- Sartorius Stedim North America Inc.
- Contact Name
- Terri Brooks
- Address
- 545-1 Johnson Ave, Bohemia
- City
- Bohemia
- State
- NY
- ZIP
- 11716
- Country
- US
- [email protected]
- Phone
- 631 4699877
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2016-05-05 |
Proprietary Names
Vivafree 2 30K (VFR02H21,VFR02H22,VFR02H23)
Vivaspin 6 (VS0601IVD, VS0602IVD)
Centrisart 100k (13269----------E)
Vivafree 500 125K (VFR01H81,VFR01H82,VFR01H83)
Vivapore 5 (VP0503, VP0501)
Vivafree 500 30K (VFR01H21,VFR01H22,VFR01H23)
Vivaspin 4 10K (VS0404, VS0405)
Vivafree 2 125K (VFR02H81,VFR02H82,VFR02H83)
Vivapore 10/20 (VP2003, VP2001, VP2002)
Vivaspin 4 Turbo (VS04T01IVD, VS04T02IVD)
Vivaspin 15 Turbo (VS15T01IVD, VS15T02IVD)
Vivaspin 20 (VS2001IVD, VS2002IVD)
Vivaspin 6 (VS0603VP)
Vivapore 5 (VP0502)
Vivaspin® Filtrate
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device