Ortec B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED SRN NL-MF-000036789
- Devices
- 4
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Ortec B.V. makes
Ortec B.V. develops the U-Prevent, a medical device designed for stroke triage and patient assessment, and a companion software application for stroke triage support. These tools are intended to assist in early identification and prioritization of stroke cases to improve clinical outcomes.
The company’s products fall under EU Device Classes I and IIa and are registered in the EUDAMED database. Ortec B.V. is based in the Netherlands.
Catalogue
- CE MDR EUDAMED
- CE MDR CE MDD EUDAMED
Stroke Triage App Ref Acute Care Triage
CE MDR, withdrawn EUDAMED- CE MDR, withdrawn EUDAMED
Company details
- EUDAMED SRN
- NL-MF-000036789
- EU VAT number
- NL818500529B01
- EUDAMED status
- Active
- EUDAMED registered name
- ORTEC B.V.
- Registered address
- 5, Houtsingel, 2719 EA, Zoetermeer, Netherlands
- Website
- ortec.com/
- linkedin.com/company/ortec
- [email protected]
- Phone
- +31 88 678 32 65
- PRRC contact
- Inés Beekers
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 15 Jun 2031
Notified body 1912 1 certificate
- P000535115CRT01 Issued
Quality management system EU MDR
- Issued
- 15 Jun 2026
- Expires
- 15 Jun 2031
From the company website
ORTEC software uses AI to optimize supply chain planning and workforce management. Boost reliability and focus on what matters. Discover how it works now!
Frequently asked questions
How many devices does ORTEC B.V. have in the registry?
The registry currently lists 4 devices for ORTEC B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ORTEC B.V.'s devices?
Among its 4 most recently registered devices, ORTEC B.V. has devices listed in EUDAMED (4 devices).
What risk classes do ORTEC B.V.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for ORTEC B.V.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ORTEC B.V.?
EUDAMED lists 1 certificate for ORTEC B.V. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-06-15.
What are the newest devices from ORTEC B.V. in the registry?
The most recently registered devices listed for ORTEC B.V. include Acute Care Triage, U-Prevent and Stroke Triage App.