Kinetikos - Driven Solutions, Lda
Active in EUDAMEDPortugalfrom SRN EUDAMED SRN PT-MF-000012965
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
0 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Kinetikos - Driven Solutions, Lda makes
Kinetikos produces motion analysis and gait assessment devices, including the mKinetikos and KinetikOS systems, which utilize wearable technology to capture movement data. These tools enable real-time gait and motion analysis without requiring specialized lab equipment, allowing evaluations in natural environments. The Kinetikos platform integrates these devices to provide comprehensive motion tracking solutions for clinical and research applications.
The company’s devices are classified under EU medical device regulations as Class I and Class IIa, with all products listed in the EU’s eudamed registry. The manufacturer is based in Portugal and adheres to relevant EU medical device directives and regulations for market placement.
Catalogue
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- PT-MF-000012965
- EU VAT number
- 513776788
- EUDAMED status
- Active
- EUDAMED registered name
- Kinetikos - Driven Solutions, Lda
- EUDAMED abbreviated name
- Kinetikos
- Registered address
- C, Rua Pedro Nunes, 3030-199, Coimbra, Portugal
- Website
- kinetikoshealth.com/
- [email protected]
- PRRC contact
- Ricardo Matias
EUDAMED certificates
1 certificate0 valid, 0 expired, 1 withdrawn or suspendedMDR 1
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1938329-1 Withdrawn
Quality management system EU MDR
- Issued
- 19 Jun 2023
- Expires
- 18 Jun 2028
- Reason
- Failure contractual obligations
From the company website
KinetikOS measures gait and mobility from the smartphone a person already carries, for clinical research, partner platforms and remote care. No wearable required.
Frequently asked questions
How many devices does Kinetikos - Driven Solutions, Lda have in the registry?
The registry currently lists 3 devices for Kinetikos - Driven Solutions, Lda. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kinetikos - Driven Solutions, Lda's devices?
Among its 3 most recently registered devices, Kinetikos - Driven Solutions, Lda has devices listed in EUDAMED (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Kinetikos - Driven Solutions, Lda's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Kinetikos - Driven Solutions, Lda's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Kinetikos - Driven Solutions, Lda?
EUDAMED lists 1 certificate for Kinetikos - Driven Solutions, Lda (quality management system) under MDR. The most recent was issued on 19 Jun 2023.
What are the newest devices from Kinetikos - Driven Solutions, Lda in the registry?
The most recently registered devices listed for Kinetikos - Driven Solutions, Lda include mKinetikos, KinetikOS and Kinetikos platform.