DRTECH Corporation
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000012441 FEI 3005172103
DRTECH Corporation is a medical device manufacturer based in South Korea, with 25 devices listed in FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 13 Nov 2026.
- Devices
- 25
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 24
- EUDAMED 2
- Device classes
- FDA Class II 24
- EU Class IIa 1
- Top EMDN categories
- Sites and related companies
- DRTECH Europe GmbH authorised representative
- Identifiers
- EUDAMED SRN KR-MF-000012441
- FDA FEI 3005172103
- DUNS 689842626
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- DRTECH Europe GmbHDE
What DRTECH Corporation makes
DRTech Corporation manufactures stationary digital X-ray systems for basic diagnostic imaging, including fixed tabletop units like the AIDIA Luxe and wall-mounted systems such as the EXTRON series (EXTRON 3, 5, 7). Their portfolio also includes portable and mobile X-ray devices, including the EXSYS DEXi series with various detector configurations, as well as digital radiography systems like the EVS 4343 and EXPD models. Console-based solutions, such as the RConsole1 and EConsole2, are integrated with certain imaging systems for enhanced workflow control.
These devices are classified under EU regulations as Class II, Class IIa, and Class IIb, and are listed in the EUDAMED database and the FDA’s 510(k) registry. The company is based in South Korea.
Catalogue
Search and filter all 25 devicesCompany details
- EUDAMED SRN
- KR-MF-000012441
- FDA FEI number
- 3005172103
- DUNS number
- 689842626
- EUDAMED status
- Active
- EUDAMED registered name
- DRTECH Corporation
- EUDAMED abbreviated name
- DRTECH
- Registered address
- 541 beon-gil, Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero, 13216, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
- Website
- www.drtech.com
- drtechra@drtech.com
- PRRC contact
- Heejoo Lee
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 11 Sep 2029
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2033753-1 Active
Quality management system EU MDR
- Issued
- 11 Apr 2025
- Expires
- 11 Sep 2029
- Reason
- Other
FDA establishments
- Drtech Corp. Seongnam-si Gyeonggi · KR FEI 3024891354
Frequently asked questions
How many devices does DRTECH Corporation have in the registry?
The registry currently lists 25 devices for DRTECH Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list DRTECH Corporation's devices?
Among its 25 most recently registered devices, DRTECH Corporation has devices listed in EUDAMED (2 devices) and FDA 510(k) (24 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do DRTECH Corporation's devices fall under?
Among its 25 most recently registered devices, the classes recorded for DRTECH Corporation's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for DRTECH Corporation?
EUDAMED lists 1 certificate for DRTECH Corporation (quality management system) under MDR. The most recent was issued on 11 Apr 2025.
What are the newest devices from DRTECH Corporation in the registry?
The most recently registered devices listed for DRTECH Corporation include EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP, EXSYS DEXi (EXSYS DEXi-S40S), EXTRON 3 and EXTRON 3; EXTRON 5; EXTRON 7.
Which FDA establishments are linked to DRTECH Corporation?
1 FDA establishment is linked to DRTECH Corporation in the registry; they are listed on the company page.