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Drtech Corp.

Active in EUDAMED

Registered as DRTECH Corporation (DRTECH) in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000012441 FEI 3024891354

Part of DRTECH Corporation

Drtech Corp. is a medical device manufacturer based in South Korea, with 100 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa and IIb) as of 13 Nov 2026.

Devices
100
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 79
  • EUDAMED 63
  • FDA 510(k) 6

A device listed in two registries counts in both.

Device classes
  • FDA Class II 54
  • EU Class IIa 28
  • EU Class IIb 11
  • FDA Class I 7
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000012441
  • FDA FEI 3024891354

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI

What Drtech Corp. makes

Drtech Corp. manufactures diagnostic imaging equipment including stationary basic diagnostic x-ray systems, mobile general-purpose fluoroscopic x-ray systems, stationary mammographic x-ray systems, and related components such as indirect flat panel x-ray detectors, x-ray film cassette holders, and diagnostic x-ray digital imaging conversion systems. They also produce radiology DICOM image processing application software and diagnostic X-ray system image receptor floor stands.

The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) and FDA UDI registries.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue100

Newest first, rows 1-50 of 100

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  • AIDIA Volve Ref AIDIA Volve-XT

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • EXSYS DEXi Ref EXSYS DEXi-S40S

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • AIDIA Volve Ref AIDIA Volve-HT

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • EXSYS DEXi Ref EXSYS DEXi-S40P

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • EXSYS DEXi Ref EXSYS DEXi-S50H

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • EXSYS DEXi Ref EXSYS DEXi-S40T

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Mobile Fluoroscopic X-ray System Ref EXTRON 6

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Expd 3643D

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Expd 4343S

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Expd 4343D

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EConsole2

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • XERO-alpha XERO α

    Active Regimes: 510(k) Registry: GUDID Class:II

  • AIDIA Volve Ref AIDIA Volve-HS

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • AIDIA Volve Ref AIDIA Volve-XS

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Digital Mammography System Ref AIDIA Luxe

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Exprimer EVS 2430W

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Exprimer EVS 3643WG

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EXSYS DEXi-D402S-FRA

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Exprimer EVS 4343G

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Flaatz 600

    Listed Registry: GUDID Class:II

  • Exprimer EVS 4343

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Flaatz 760

    Listed Registry: GUDID Class:II

  • EXSYS DEXi-A402S-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Flaatz 601

    Listed Registry: GUDID Class:II

  • EXSYS DEXi-A503T-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Exprimer EVS 3643

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Expd 114, Expd 114g, Expd 114P, Expd 114PG

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • LLD 129 Samsung

    Listed Registry: GUDID Class:I

  • EXSYS DEXi-D503T-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-D503T-FRA

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-D401P-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Expd 4357

    Active Regimes: 510(k) Registry: GUDID Class:II

  • LLD 129 Basic

    Listed Registry: GUDID Class:I

  • RoseM RSM 1824C

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Flaatz 560

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Exprimer EVS 4343WG

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EXPD-N series EXPD 3643NP

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Expd 4357P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • EXSYS DEXi-D402P-FRA

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-D402P-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-D401S-FRA

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Flaatz 750E

    Listed Registry: GUDID Class:II

  • Extron 3

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-D401P-FRA

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-A401S-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EConsole1

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-A401P-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • EXSYS DEXi-D401S-FRM

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Exprimer EVS 3643AG

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Exprimer EVS 3643G

    Active Regimes: 510(k) Registry: GUDID Class:II

Rows 1-50 of 100

Showing 1-50 of 100

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000012441
FDA FEI number
3024891354
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
PRRC contact
Heejoo Lee(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 11 Sep 2029

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 2033753-1 Active Supplemented

    Quality management system EU MDR

    Issued
    11 Apr 2025
    Expires
    11 Sep 2029
    Reason
    Other

Frequently asked questions

How many devices does Drtech Corp. have in the registry?

The registry currently lists 100 devices for Drtech Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Drtech Corp.'s devices?

Among its 50 most recently registered devices, Drtech Corp. has devices listed in EUDAMED (28 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Drtech Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Drtech Corp.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Drtech Corp.?

EUDAMED lists 1 certificate for Drtech Corp. (quality management system) under MDR. The most recent was issued on 11 Apr 2025.

What are the newest devices from Drtech Corp. in the registry?

The most recently registered devices listed for Drtech Corp. include AIDIA Volve, EXSYS DEXi, Mobile Fluoroscopic X-ray System and EXPD 3643D.

Generated automatically from registry data and not verified by a human reviewer.