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Netherlands·NL-MF-000018307
Last updated May 30, 2026
What XVIVO B.V. makes
XVIVO B.V. manufactures kidney and liver donor-organ preservation and transport systems. Their product portfolio includes perfusion sets and transport devices such as the Kidney Assist, Liver Assist, and their associated perfusion sets.
The company is based in the Netherlands and maintains devices classified as Class II, Class IIa, and Class IIb. These products are listed in the EUDAMED database and the FDA UDI registry.
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 XVIVO B.V. manufacture?
XVIVO B.V. specializes in the production of donor-organ preservation and transport systems. Their product portfolio primarily focuses on kidney and liver perfusion technologies, including the Kidney Assist and Liver Assist systems, as well as their associated perfusion sets designed to support organ viability during transport.
Where is XVIVO B.V. based?
XVIVO B.V. is based in the Netherlands. This location serves as the primary base for the company's operations regarding the development and manufacturing of their organ preservation and transport technologies.
How are the devices from XVIVO B.V. classified?
The devices manufactured by XVIVO B.V. fall under three distinct regulatory classifications: Class II, Class IIa, and Class IIb. These classifications are determined by the specific risk profile and intended use of each individual perfusion or transport device within their product line.
Which regulatory registries list the devices produced by XVIVO B.V.?
The devices manufactured by XVIVO B.V. are listed in the EUDAMED database and the FDA UDI registry. These listings provide transparency and regulatory oversight for their kidney and liver organ preservation and transport systems across the relevant jurisdictions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Netherlands
- Address
- 84, Bornholmstraat, Groningen, Netherlands
- Website
- www.xvivogroup.com
- —
- —
- [email protected]
- Phone
- +31 50 3131905
- PRRC Contact
- Steven Boom
- EUDAMED SRN
- NL-MF-000018307
- FDA FEI Number
- —
- DUNS Number
- 489176113
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kidney Assist™ | 21.101 | EUDAMED | Class IIb | Active |
| Liver Assist™ Perfusion Set - Single | 13.401 | EUDAMED | Class IIa | Active |
| Kidney Assist™ Perfusion Set | 21.401 | EUDAMED | Class IIa | Active |
| Kidney Assist Transport | Kidney Assist Transport | FDA UDI | Class II | Active |
| Kidney Assist Transport Perfusion set | Kidney Assist Transport Perfusion set | FDA UDI | Class II | Active |
| Liver Assist Perfusion Set | 11.401 | EUDAMED | Class IIa | Active |
| Liver Assist | 11.101 | EUDAMED | Class IIb | Active |
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