Prolira BV
Active in EUDAMEDNetherlandsfrom SRN EUDAMED SRN NL-MF-000000253
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
0 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Prolira BV makes
Prolira BV manufactures continuous glucose monitoring systems, including the DeltaScan Monitor—a portable device for real-time glucose level tracking—and the DeltaScan Patch, a wearable sensor for subcutaneous glucose measurement. These products are designed for patients requiring frequent glucose monitoring, such as those with diabetes.
The company’s devices are classified under EU Medical Device Regulations as Class I and Class IIa, with both the DeltaScan Monitor and DeltaScan Patch listed in the EU’s eudamed registry. Prolira BV is based in the Netherlands.
Catalogue
DeltaScan Monitor Ref 006.000.A
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDIDDeltaScan Patch Ref 009.000.B
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- NL-MF-000000253
- EU VAT number
- NL854784019B01
- EUDAMED status
- Active
- EUDAMED registered name
- Prolira BV
- EUDAMED abbreviated name
- Prolira
- Registered address
- 8, Padualaan, 3584 CH, Utrecht, Netherlands
- Website
- www.prolira.com
- [email protected]
- Phone
- +31647762936
- PRRC contact
- Uschi Oudt
EUDAMED certificates
1 certificate0 valid, 0 expired, 1 withdrawn or suspendedMDR 1
Kiwa Assurance B.V. 1912 1 certificate
- 23M00031CRT01 Withdrawn
Quality management system EU MDR
- Issued
- 17 Jun 2023
- Expires
- 17 Jun 2028
- Reason
- Other
Frequently asked questions
How many devices does Prolira BV have in the registry?
The registry currently lists 2 devices for Prolira BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prolira BV's devices?
Among its 2 most recently registered devices, Prolira BV has devices listed in EUDAMED (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Prolira BV's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Prolira BV's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Prolira BV?
EUDAMED lists 1 certificate for Prolira BV (quality management system) under MDR. The most recent was issued on 17 Jun 2023.
What are the newest devices from Prolira BV in the registry?
The most recently registered devices listed for Prolira BV include DeltaScan Monitor and DeltaScan Patch.