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Ami Inc.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000017522 FEI 3014253920

Ami Inc. is a medical device manufacturer based in South Korea, with 34 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (EU Class IIb and IIa; FDA Class II) as of 13 Nov 2026.

Devices
34
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 31
  • FDA 510(k) 3
  • FDA GUDID 3

A device listed in two registries counts in both.

Device classes
  • EU Class IIb 27
  • EU Class IIa 4
  • FDA Class II 3
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000017522
  • FDA FEI 3014253920
  • DUNS 689004697

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
Obelis S.A.BE

Catalogue34

Newest first, rows 1-34 of 34

Search and filter all 34 devices
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  • Q-Switched Nd:YAG Laser System Ref K172908

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

  • Dermaxel Ref AMI-CL-0411

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Rex-Q Ref AMI-CL-0331A

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Rex-Q Plus Ref AMI-CL-0332A

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Viola Ref AMI-CL-0811

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Antige Ref AMI-CL-0911

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Bioxel

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb

  • Rex-An Dual Ref AMI-CL-0621

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Haclre Ref AMI-CL-0211

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Rex-An Alex Ref AMI-CL-0622

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • DX300 Ref AMI-CL-0541

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Picosecond Nd:YAG Laser System; PICO LEGEND Ref K233007

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

  • Fractional CO2 Surgical Laser System Ref K173359

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

  • Solray Ref AMI-CL-0711

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • BX300 Ref AMI-CL-0531

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Allux-Q Plus Ref AMI-CL-0332

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Ann-36 Ref AMI-CL-0911

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Q-Master Plus Ref AMI-CL-0322

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • ALLUX Nd:YAG Ref AMI-CL-0613

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Neoxel Ref AMI-CL-0511

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Hi-Rex Ref AMI-CL-0841

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Mt-Smart Ref AMI-CL-0941

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Rex-Co Ref AMI-CL-0421

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • REX-AN Nd:YAG Ref AMI-CL-0623

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Rex-Light Ref AMI-CL-0711

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Allux-Q Ref AMI-CL-0331

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Q-Master Ref AMI-CL-0321

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb

  • Ani-36 Ref AMI-CL-0911

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Pico Legend Ref AMI-CL-1011

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb

  • Allux Alex Ref AMI-CL-0612

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Di-Rex Ref AMI-CL-0221

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Pico Master Ref AMI-CL-1021

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Allux Dual Ref AMI-CL-0611

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Ant-36 Ref AMI-CL-0911

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

Rows 1-34 of 34

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000017522
FDA FEI number
3014253920
DUNS number
689004697
EU VAT number
1198651879
EUDAMED status
Active
EUDAMED registered name
AMI INC.
Registered address
278, Beotkkot-ro, Geumcheon-gu, 08511, Seoul, South Korea
Phone
+82-2-3281-9091
PRRC contact
MinGyun Ko(public in EUDAMED)

Frequently asked questions

How many devices does AMI INC. have in the registry?

The registry currently lists 34 devices for AMI INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list AMI INC.'s devices?

Among its 34 most recently registered devices, AMI INC. has devices listed in EUDAMED (31 devices), FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do AMI INC.'s devices fall under?

Among its 34 most recently registered devices, the classes recorded for AMI INC.'s devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What are the newest devices from AMI INC. in the registry?

The most recently registered devices listed for AMI INC. include Q-Switched Nd:YAG Laser System, DERMAXEL, REX-Q and REX-Q PLUS.

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