NEXUS ASTRAIA B.V.
Netherlands NL-MF-000002707 Last updated 17 Sep 2026
- Devices
- 3
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Mosos CTG Ref Software version 13.1
Mosos CTG 12.15.XX Ref Mosos CTG
Mosos CTG Ref Software version 13.0
EUDAMED certificates
Notified body 0344 1 certificate
- 2268297CE01 Amended
Quality management system EU MDR
- Issued
- 24 Mar 2026
- Expires
- 1 Jul 2029
- Reason
- Mnf data change
Related companies
Notified bodies
- Notified body 0344
About
For astraia software support in BENELUX, please visit Sorg-Saem, the local astraia partner. For international astraia software customers please visit the astraia website directly.
What NEXUS ASTRAIA B.V. makes
Nexus Astraia B.V. manufactures the Mosos CTG, a fetal monitoring device used for continuous cardiotocography (CTG) to track fetal heart rate and uterine contractions during pregnancy and labor.
The Mosos CTG is classified as a Class IIb medical device and is listed in the EU’s eudamed registry. The company is based in the Netherlands.
Frequently asked questions
What types of medical devices does Nexus Astraia B.V. manufacture?
Nexus Astraia B.V. specializes in fetal monitoring devices. Specifically, they produce the Mosos CTG, which is designed for continuous cardiotocography (CTG) to monitor fetal heart rate and uterine contractions during pregnancy and labor. This device helps healthcare providers assess fetal well-being in real-time.
Where is Nexus Astraia B.V. based?
Nexus Astraia B.V. is based in the Netherlands. The company operates within the country while also providing support for its software solutions through local partners like Sorg-Saem in the Benelux region and directly via its website for international customers.
Which regulatory registries list Nexus Astraia B.V.’s devices?
The Mosos CTG, Nexus Astraia B.V.’s primary device, is listed in the EU’s eudamed registry. This registry is used to track medical devices that have been authorized for placement on the European market, ensuring transparency and traceability.
How are Nexus Astraia B.V.’s devices classified under EU regulations?
The Mosos CTG is classified as a Class IIb medical device under EU regulations. This classification is determined based on the device’s intended purpose and potential risks. Class IIb devices are considered to have a moderate risk and require additional scrutiny, including conformity assessment procedures, to ensure their safety and performance.
Information
- Country
- Netherlands
- Address
- 3, Lage Biezenweg , Vianen, Netherlands
- Website
- www.nexus-astraia.nl
- linkedin.com/company/ict-hcts
- [email protected]
- Phone
- +31 30 666 5021
- PRRC contact
- Ivana Spehar
- EUDAMED SRN
- NL-MF-000002707