Ainex Corporation
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000053360
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
ENAD CADx Ref ENAD-CADx-01
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000053360
- EUDAMED status
- Active
- EUDAMED registered name
- Ainex Corporation
- Registered address
- 22, Teheran-ro 108-gil, 06174, Seoul, Gangnam-gu, South Korea
- Website
- ainex.io/
- linkedin.com/company/ainex
- facebook.com/enad.channel
- [email protected]
- Phone
- +82 70-5222-5623
- PRRC contact
- Hyejin Kil
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 5 Oct 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 137725 0002 Active
Quality management system EU MDR
- Issued
- 6 Oct 2026
- Expires
- 5 Oct 2031
From the company website
INEX(Ainex) PRESENTS NEW STANDARDS IN THE FIELD OF LONG-TERM VISION AND LONG-TERM VISION THROUGH REAL-TIME AI ENDOSCOPE DIAGNOSTIC AID SOFTWARE ENAD.
Frequently asked questions
How many devices does Ainex Corporation have in the registry?
The registry currently lists 1 device for Ainex Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ainex Corporation's devices?
Among its 1 most recently registered device, Ainex Corporation has devices listed in EUDAMED (1 device).
What risk classes do Ainex Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ainex Corporation's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Ainex Corporation?
EUDAMED lists 1 certificate for Ainex Corporation (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 6 Oct 2026.
What are the newest devices from Ainex Corporation in the registry?
The most recently registered devices listed for Ainex Corporation include ENAD CADx.