Kinepict Health, Ltd.
Active in EUDAMEDHungaryfrom SRN EUDAMED SRN HU-MF-000019155
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Kinepict Health, Ltd. makes
Kinepict Health, Ltd. manufactures medical imaging tools, specifically the Kinepict Medical Imaging Tool version v2.2 and Kinepict Medical Imaging Tool 4.0.
These devices are Class II and listed in the FDA 510(k) registry. The company is based in the US.
Catalogue
Kinepict Medical Imaging Tool Ref KMIT 7.1
Regimes: CE MDR Registry: EUDAMEDKinepict Medical Imaging Tool version v2.2 Ref K190993
Regimes: 510(k) Registry: 510(k)Kinepict Medical Imaging Tool 4.0 Ref K202056
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- HU-MF-000019155
- EU VAT number
- HU 25449543
- EUDAMED status
- Active
- EUDAMED registered name
- Kinepict Health Ltd.
- Registered address
- 5, Kelta köz, 2092, Budakeszi, Hungary
- Website
- www.kinepict.com
- [email protected]
- Phone
- 36317852784
- PRRC contact
- Balazs Elekes
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 Dec 2029
DNV Product Assurance AS 2460 1 certificate
- C555017 Active
Quality management system EU MDR
- Issued
- 13 Dec 2024
- Expires
- 13 Dec 2029
Frequently asked questions
How many devices does Kinepict Health, Ltd. have in the registry?
The registry currently lists 3 devices for Kinepict Health, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kinepict Health, Ltd.'s devices?
Among its 3 most recently registered devices, Kinepict Health, Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Kinepict Health, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Kinepict Health, Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Kinepict Health, Ltd.?
EUDAMED lists 1 certificate for Kinepict Health, Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 13 Dec 2024.
What are the newest devices from Kinepict Health, Ltd. in the registry?
The most recently registered devices listed for Kinepict Health, Ltd. include Kinepict Medical Imaging Tool, Kinepict Medical Imaging Tool version v2.2 and Kinepict Medical Imaging Tool 4.0.