Arineta, Ltd.
Active in EUDAMEDIsraelfrom SRN EUDAMED SRN IL-MF-000028266
Arineta, Ltd. is a medical device manufacturer based in Israel, with 10 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II; EU Class IIb) as of 13 Nov 2026.
- Devices
- 10
- Registrations
- EUDAMED
Registry facts
- Registries
- FDA 510(k) 5
- EUDAMED 3
- FDA GUDID 3
- Device classes
- FDA Class II 8
- EU Class IIb 2
- Top EMDN categories
- Sites and related companies
- Arineta Ltd. Israel
- Identifiers
- EUDAMED SRN IL-MF-000028266
- DUNS 514896484
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Arineta, Ltd. makes
Arineta, Ltd. manufactures computed tomography (CT) systems designed for full-body imaging, including models tailored for cardiac and lung cancer screening. The portfolio includes systems like the SpotLight and SpotLight Duo, which offer low-dose imaging capabilities, as well as the CardioGraphe for cardiac assessments. Some variants incorporate dual low-dose imaging reconstruction (DLIR) and specialized screening options for lung cancer detection.
The company’s devices are classified under FDA’s Class II regulatory category and are listed under the 510(k) and UDI programs. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
SpotLight Duo Ref 07290016484052
Regimes: CE MDR Registry: EUDAMEDSpotLight Ref 07290016484045
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
SpotLight CT Ref K161066
Regimes: 510(k) Registry: 510(k)SpotLight/SpotLight Duo (with DLIR option) Ref K230370
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
CardioGraphe Ref K213465
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- IL-MF-000028266
- DUNS number
- 514896484
- EU VAT number
- 513842740
- EUDAMED status
- Active since 2021
- EUDAMED registered name
- Arineta
- EUDAMED abbreviated name
- Arineta
- Registered address
- 15, Halamish, 3088900, Caesarea, Israel
- Website
- WWW.ARINETA.COM
- Phone
- 972 4 6374005
- PRRC contact
- Einav Ehre
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Mar 2031
DEKRA Certification B.V. 0344 1 certificate
- 3903104CE01 Active
Quality management system EU MDR
- Issued
- 14 Jul 2026
- Expires
- 1 Mar 2031
- Reason
- Other
Sites
- Arineta Ltd. ILFEI 3010642685 0 devices
Frequently asked questions
How many devices does Arineta, Ltd. have in the registry?
The registry currently lists 10 devices for Arineta, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arineta, Ltd.'s devices?
Among its 10 most recently registered devices, Arineta, Ltd. has devices listed in EUDAMED (3 devices), FDA 510(k) (5 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Arineta, Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Arineta, Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Arineta, Ltd.?
EUDAMED lists 1 certificate for Arineta, Ltd. (quality management system) under MDR. The most recent was issued on 14 Jul 2026.
What are the newest devices from Arineta, Ltd. in the registry?
The most recently registered devices listed for Arineta, Ltd. include SpotLight Duo, SpotLight, CardioGraphe Spotlight and SpotLight CT.