DigiMed Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000016608
DigiMed Co., Ltd. is a medical device manufacturer based in South Korea, with 15 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb) as of 15 Nov 2026.
- Devices
- 15
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 11
- EUDAMED 7
- FDA 510(k) 4
- Device classes
- FDA Class II 13
- EU Class IIb 2
- Top EMDN categories
- Sites and related companies
- KTR Europe GmbH authorised representative
- Identifiers
- EUDAMED SRN KR-MF-000016608
- DUNS 688265810
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- KTR Europe GmbHDE
What DigiMed Co., Ltd. makes
DigiMed Co., Ltd. manufactures intraoral digital imaging sensors for dental use, including standalone models like the DMC-04 and DMC-07, as well as hybrid systems combining intraoral and extraoral capabilities (e.g., HYBRID S70, Hybrid C70). Their portfolio also includes portable X-ray systems such as the MiniX-V and Mini X-S, designed for flexible dental radiography. Additional intraoral sensors include the DHX-70H and XTG-70H, optimized for high-resolution imaging.
The company’s devices are classified under EU Medical Device Regulation (MDR) as Class II and Class IIb, with corresponding submissions in the EUDAMED registry. These products are also listed under the FDA’s 510(k) clearance pathway in the United States. DigiMed Co., Ltd. is headquartered in South Korea.
Catalogue
Search and filter all 15 devicesCompany details
- EUDAMED SRN
- KR-MF-000016608
- DUNS number
- 688265810
- EU VAT number
- 119-81-51326
- EUDAMED status
- Active
- EUDAMED registered name
- DIGIMED Co., Ltd.
- Registered address
- 101, Gasan digital 2-ro, Geoumcheon-gu, 08505, Seoul, South Korea
- Website
- www.digimed.co.kr
- digi-med@hanmail.net
- Phone
- +82 2 6265 1551
- PRRC contact
- Youngdon Moon
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 21 Jun 2029
DNV Product Assurance AS 2460 1 certificate
- C533314 Active
Quality management system EU MDR
- Issued
- 21 Jun 2024
- Expires
- 21 Jun 2029
FDA establishments
- Digimed Corporation US
Frequently asked questions
How many devices does DigiMed Co., Ltd. have in the registry?
The registry currently lists 15 devices for DigiMed Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list DigiMed Co., Ltd.'s devices?
Among its 15 most recently registered devices, DigiMed Co., Ltd. has devices listed in EUDAMED (7 devices), FDA 510(k) (4 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do DigiMed Co., Ltd.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for DigiMed Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for DigiMed Co., Ltd.?
EUDAMED lists 1 certificate for DigiMed Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 21 Jun 2024.
What are the newest devices from DigiMed Co., Ltd. in the registry?
The most recently registered devices listed for DigiMed Co., Ltd. include XTG 1, XTG V 1, XTG PRO 70 HYBRID Pro and DIOX-602 1.
Which FDA establishments are linked to DigiMed Co., Ltd.?
1 FDA establishment is linked to DigiMed Co., Ltd. in the registry; they are listed on the company page.