Otivio AS
Active in EUDAMEDNorwayfrom SRN EUDAMED SRN NO-MF-000007971
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
FlowOx™ Blood Flow Enhancement System Ref 900-00018
Regimes: CE MDR Registry: EUDAMEDFlowOx™ Blood Flow Enhancement System Ref 900-00017
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- NO-MF-000007971
- EU VAT number
- 995042762
- EUDAMED status
- Active
- EUDAMED registered name
- Otivio AS
- Registered address
- 130, Drammensveien, 0277, Oslo, Norway
- Website
- www.flowox.com/
- linkedin.com/company/otivio-as
- facebook.com/flowoxotivio
- [email protected]
- PRRC contact
- Punit Patel
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 29 Aug 2029
DNV Product Assurance AS 2460 1 certificate
- C576271 Active
Quality management system EU MDR
- Issued
- 30 Aug 2024
- Expires
- 29 Aug 2029
From the company website
Otivio AS is a Norwegian medtech company based in Oslo. FlowOx™ is a non-invasive medical device for home treatment addressing insufficient blood flow to the limbs associated with peripheral arterial disease, diabetes and other arterial blood flow deficiencies. FlowOx™ is documented to reduce or eliminate these outcomes which represent a big impact on Quality of Life and health care costs. FlowOx™ is CE marked (CE2460) and available in various countries.
Frequently asked questions
How many devices does Otivio AS have in the registry?
The registry currently lists 2 devices for Otivio AS. Devices recorded under merged duplicate company entries are counted once.
Which registries list Otivio AS's devices?
Among its 2 most recently registered devices, Otivio AS has devices listed in EUDAMED (2 devices).
What risk classes do Otivio AS's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Otivio AS's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Otivio AS?
EUDAMED lists 1 certificate for Otivio AS (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 30 Aug 2024.
What are the newest devices from Otivio AS in the registry?
The most recently registered devices listed for Otivio AS include FlowOx™ Blood Flow Enhancement System.