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Sign in to claim this brandWhat SARTORIUS STEDIM LAB LIMITED makes
The company manufactures in vitro diagnostic (IVD) devices for laboratory use, including centrifugal filtration systems like the Vivafree series and Vivaspin series, which are designed for sample preparation and concentration. It also produces laboratory dialysers such as the Vivapore series, used for protein and buffer exchange in biochemical applications.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sartorius Stedim Lab Limited manufacture?
Sartorius Stedim Lab Limited specializes in in vitro diagnostic (IVD) devices primarily for laboratory use. Their products include centrifugal filtration systems like the Vivafree and Vivaspin series, which are used for sample preparation and concentration, as well as laboratory dialysers such as the Vivapore series. These devices are designed for biochemical applications like protein and buffer exchange.
Where is Sartorius Stedim Lab Limited based?
The company is based in the United States. This location is relevant for regulatory compliance and distribution, as their devices are subject to FDA oversight.
Which regulatory registries list Sartorius Stedim Lab Limited’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability.
How are Sartorius Stedim Lab Limited’s devices classified under FDA regulations?
The devices produced by Sartorius Stedim Lab Limited fall under Class I classification according to FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, often requiring less stringent premarket review.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sartorius.com
- —
- —
- [email protected]
- Phone
- +16318708528
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 345881551
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vivafree 2 | VFR02H21 | FDA UDI | Class I | Active |
| Vivaspin 4 | VS0405 | FDA UDI | Class I | Active |
| Vivaspin Turbo 15 | VS15T01IVD | FDA UDI | Class I | Active |
| Vivaspin Turbo 15 | VS15T02IVD | FDA UDI | Class I | Active |
| Vivafree 2 | VFR02H83 | FDA UDI | Class I | Active |
| Vivapore 10/20 | VP2001 | FDA UDI | Class I | Active |
| Vivaspin 6 | VS0602IVD | FDA UDI | Class I | Active |
| Vivafree 2 | VFR02H23 | FDA UDI | Class I | Active |
| Vivapore 10/20 | VP2003 | FDA UDI | Class I | Active |
| Vivaspin Turbo 4 | VS04T01IVD | FDA UDI | Class I | Active |
| Vivafree 500 | VFR01H83 | FDA UDI | Class I | Active |
| Vivafree 500 | VFR01H22 | FDA UDI | Class I | Active |
| Vivafree 500 | VFR01H23 | FDA UDI | Class I | Active |
| Vivafree 500 | VFR01H21 | FDA UDI | Class I | Active |
| Vivapore 5 | VP0503 | FDA UDI | Class I | Active |
| Vivapore 10/20 | VP2002 | FDA UDI | Class I | Active |
| Vivaspin 20 | VS2002IVD | FDA UDI | Class I | Active |
| Centrisart 1 | 13269---------E | FDA UDI | Class I | Unknown |
| Vivafree 500 | VFR01H81 | FDA UDI | Class I | Active |
| Vivaspin 6 | VS0603VP | FDA UDI | Class I | Active |
| Vivaspin 6 | VS0601IVD | FDA UDI | Class I | Active |
| Vivafree 2 | VFR02H82 | FDA UDI | Class I | Active |
| Vivaspin Turbo 4 | VS04T02IVD | FDA UDI | Class I | Active |
| Vivapore 5 | VP0501 | FDA UDI | Class I | Active |
| Vivaspin 4 | VS0403 | FDA UDI | Class I | Unknown |
| Vivaspin 20 | VS2001IVD | FDA UDI | Class I | Active |
| Vivapore 5 | VP0502 | FDA UDI | Class I | Active |
| Vivafree 500 | VFR01H82 | FDA UDI | Class I | Active |
| Vivaspin 4 | VS0404 | FDA UDI | Class I | Unknown |
| Vivafree 2 | VFR02H22 | FDA UDI | Class I | Active |
| Vivaspin Filtrate | 13269----------E | FDA UDI | Class I | Active |
| Vivafree 2 | VFR02H81 | FDA UDI | Class I | Active |
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