Sirius Medical Systems B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED FDA SRN NL-MF-000010932 FEI 3020733550
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
Catalogue
Sirius Pintuition Seed 20cm Ref SPS20
Regimes: CE MDR Registry: EUDAMED- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- NL-MF-000010932
- FDA FEI number
- 3020733550
- EU VAT number
- NL857316382B01
- EUDAMED status
- Active
- EUDAMED registered name
- Sirius Medical Systems B.V.
- EUDAMED abbreviated name
- Sirius Medical
- Registered address
- 41, High Tech Campus, 5656 AE, Eindhoven, Netherlands
- Website
- www.sirius-medical.com
- [email protected]
- PRRC contact
- Erik van den Wijngaard
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 1 Dec 2030
DEKRA Certification B.V. 0344 2 certificates
- 2261039CE01 Active
Quality management system EU MDR
- Issued
- 19 Dec 2025
- Expires
- 1 Dec 2030
- 2261039TD01 Active
Technical documentation EU MDR
- Issued
- 25 Apr 2026
- Expires
- 1 Dec 2030
- Reason
- Add device or group
From the company website
Pintuition®: wire-free, non-radioactive breast localization with real-time distance and direction, plus on-target confirmation. Request a demo.
Frequently asked questions
How many devices does Sirius Medical Systems B.V. have in the registry?
The registry currently lists 4 devices for Sirius Medical Systems B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sirius Medical Systems B.V.'s devices?
Among its 4 most recently registered devices, Sirius Medical Systems B.V. has devices listed in EUDAMED (1 device) and FDA 510(k) (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sirius Medical Systems B.V.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sirius Medical Systems B.V.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Sirius Medical Systems B.V.?
EUDAMED lists 2 certificates for Sirius Medical Systems B.V. (quality management system; technical documentation) under MDR. 1 is recorded with the status issued. The most recent was issued on 25 Apr 2026.
What are the newest devices from Sirius Medical Systems B.V. in the registry?
The most recently registered devices listed for Sirius Medical Systems B.V. include Sirius Pintuition Seed 20cm and Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit.