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Neonavia AB

Sweden SE-MF-000045971 Last updated 22 Oct 2026

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Devices
5
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue5

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.

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 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.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Sweden
Address
11, Stolp-Ekeby, Vallentuna, Sweden
Phone
+46739737968
PRRC contact
Anna-Helena Uddin
EUDAMED SRN
SE-MF-000045971
FDA FEI number
3042940295