Neonavia AB
Sweden SE-MF-000045971 Last updated 22 Oct 2026
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- Devices
- 5
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
NeoNavia driver Ref REF# 1103
NeoNavia VacuPulse probe Ref REF# 2102
NeoNavia CorePulse probe Ref REF# 2103
NeoNavia FlexiPulse probe Ref REF# 2104
NeoNavia base unit Ref REF# 1102
What Neonavia AB makes
Neonavia AB manufactures ultrasound-based medical devices for vascular access procedures, including hand-held driver units and disposable probes (VacuPulse, CorePulse, FlexiPulse) designed for vein visualization and cannulation. The company also produces a base unit that interfaces with these probes to support real-time imaging and guidance during procedures.
The portfolio consists of Class IIa devices listed in the EU’s eudamed registry. Neonavia AB is headquartered in Sweden.
Frequently asked questions
What types of medical devices does Neonavia AB manufacture?
Neonavia AB specializes in ultrasound-based medical devices used for vascular access procedures. Their portfolio includes hand-held driver units and disposable probes (such as the VacuPulse, CorePulse, and FlexiPulse probes) designed to visualize veins and assist in cannulation. They also produce a base unit that connects with these probes to provide real-time imaging and procedural guidance.
Where is Neonavia AB based?
Neonavia AB is headquartered in Sweden, as indicated by the company’s country designation.
Which regulatory registries list Neonavia AB’s devices?
Neonavia AB’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices authorized under EU regulations. This registry tracks devices that meet EU requirements, including classification and compliance.
How are Neonavia AB’s devices classified under EU regulations?
Neonavia AB’s devices fall under Class IIa classification in the EU. This classification applies to devices that pose a low to moderate risk, requiring conformity assessment procedures such as a notified body review to ensure safety and performance before authorization.
Information
- Country
- Sweden
- Address
- 11, Stolp-Ekeby, Vallentuna, Sweden
- Website
- www.neonavia.se
- [email protected]
- Phone
- +46739737968
- PRRC contact
- Anna-Helena Uddin
- EUDAMED SRN
- SE-MF-000045971
- FDA FEI number
- 3042940295