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MEKICS Co., Ltd

Active in EUDAMED

South Koreafrom SRN EUDAMED SRN KR-MF-000012640

Devices
8
Registrations
EUDAMED

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
Authorised rep.
Obelis S.A.BE

What MEKICS Co., Ltd makes

MEKICS Co., Ltd manufactures mechanical ventilators, including models such as the HFT750U, MV2000, MTV1000, and HFT700, designed for respiratory support in clinical settings. These devices are intended for use in both adult and pediatric patients, providing controlled ventilation and oxygenation. The portfolio also includes features for monitoring and adjusting ventilation parameters in critical care environments. Additional models may incorporate advanced modes like pressure support and volume control for tailored patient management.

The company’s ventilators are classified under EU Medical Device Regulation as Class II and Class IIb devices, reflecting their moderate to higher-risk categorization. These products are registered in the EU’s eudamed database and have undergone 510(k) clearance through the FDA’s premarket notification process in the United States. MEKICS Co., Ltd is headquartered in South Korea, where its devices are also subject to local regulatory compliance requirements.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8

Newest first, rows 1-8 of 8

  • HFT751 Ref MCN-WM-1885

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • HFT750 Ref MCN-WM-1875

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MV50 Ref MCN-WM-1852

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • HFT750 Ref MCN-WM-1875

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • HFT750U Ref K242931

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

  • MV2000 Ref MCN-WM-1801

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • MTV1000 Ref MCN-WM-1804

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • HFT700 Ref MCN-WM-1851

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

Company details

EUDAMED SRN
KR-MF-000012640
EUDAMED status
Active
EUDAMED registered name
MEKICS Co., Ltd
Registered address
21, Sangjiseok-gil, 10911, Pajusi, South Korea
Phone
+82 70 7119 2500
PRRC contact
Sanghag Lee(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 24 Aug 2028

EUDAMED certificates (1)

DNV Product Assurance AS 2460 1 certificate

  • C575125 NoMA KOR Active

    Quality management system EU MDR

    Issued
    24 Aug 2023
    Expires
    24 Aug 2028

Frequently asked questions

How many devices does MEKICS Co., Ltd have in the registry?

The registry currently lists 8 devices for MEKICS Co., Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list MEKICS Co., Ltd's devices?

Among its 8 most recently registered devices, MEKICS Co., Ltd has devices listed in EUDAMED (7 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do MEKICS Co., Ltd's devices fall under?

Among its 8 most recently registered devices, the classes recorded for MEKICS 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 MEKICS Co., Ltd?

EUDAMED lists 1 certificate for MEKICS Co., Ltd (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 24 Aug 2023.

What are the newest devices from MEKICS Co., Ltd in the registry?

The most recently registered devices listed for MEKICS Co., Ltd include HFT751, HFT750, MV50 and HFT750U.

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