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ENGAIN Co., Ltd.

Active in EUDAMED

South Koreafrom SRN EUDAMED SRN KR-MF-000017288

Devices
1
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

Catalogue1

Newest first, rows 1-1 of 1

Company details

EUDAMED SRN
KR-MF-000017288
EU VAT number
1298671964
EUDAMED status
Active
EUDAMED registered name
ENGAIN Co., Ltd.
Registered address
10, Dongtan-daero 21-gil, 18471, Hwaseong-si, Gyeonggi-do, South Korea
PRRC contact
Suhyun Park(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 6 Jul 2031

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 2246408-1 Issued

    Quality management system EU MDR

    Issued
    7 Jul 2026
    Expires
    6 Jul 2031

Frequently asked questions

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

The registry currently lists 1 device for ENGAIN Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

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

Among its 1 most recently registered device, ENGAIN Co., Ltd. has devices listed in EUDAMED (1 device).

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

Among its 1 most recently registered device, the classes recorded for ENGAIN Co., Ltd.'s devices are Class IIa. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for ENGAIN Co., Ltd.?

EUDAMED lists 1 certificate for ENGAIN Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-07-07.

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

The most recently registered devices listed for ENGAIN Co., Ltd. include EGglue soft-tip.

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