Mriguidance B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED FDA SRN NL-MF-000002682 FEI 3027986210
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
BoneMRI Ref K260584
Regimes: 510(k) Registry: 510(k)BoneMRI Ref v1.12
Regimes: CE MDR Registry: EUDAMEDBoneMRI Ref v1.6
Regimes: CE MDR Registry: EUDAMEDBoneMRI v1.6 Ref K230197
Regimes: CE MDR 510(k) Registry: 510(k)BoneMRI Ref v1.9
Regimes: CE MDR Registry: EUDAMEDBoneMRI Ref v1.10
Regimes: CE MDR Registry: EUDAMEDBoneMRI Ref v1.7
Regimes: CE MDR Registry: EUDAMEDBoneMRI Ref v1.11
Regimes: CE MDR Registry: EUDAMEDBoneMRI Ref v1.8
Regimes: CE MDR 510(k) Registry: EUDAMED
Company details
- EUDAMED SRN
- NL-MF-000002682
- FDA FEI number
- 3027986210
- EU VAT number
- NL856499912B01
- EUDAMED status
- Active
- EUDAMED registered name
- MRIguidance B.V.
- Registered address
- 23, Maliesingel, 3581 BG, Utrecht, Netherlands
- Website
- www.mriguidance.com
- [email protected]
- Phone
- +31 681741711
- PRRC contact
- Marijn van Stralen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 2 Dec 2028
Kiwa Assurance B.V. 1912 1 certificate
- 23M00065CRT01 Active
Quality management system EU MDR
- Issued
- 23 Jul 2026
- Expires
- 2 Dec 2028
- Reason
- Other
Frequently asked questions
How many devices does Mriguidance B.V. have in the registry?
The registry currently lists 9 devices for Mriguidance B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mriguidance B.V.'s devices?
Among its 9 most recently registered devices, Mriguidance B.V. has devices listed in EUDAMED (7 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Mriguidance B.V.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Mriguidance B.V.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Mriguidance B.V.?
EUDAMED lists 1 certificate for Mriguidance B.V. (quality management system) under MDR. The most recent was issued on 23 Jul 2026.
What are the newest devices from Mriguidance B.V. in the registry?
The most recently registered devices listed for Mriguidance B.V. include BoneMRI and BoneMRI v1.6.