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Hi-Rex

by Ami Inc.

Ref AMI-CL-0841Model HI-REX

Hi-Rex (AMI-CL-0841) is a Class IIa device made by Ami Inc., registered in EUDAMED on 17 Jun 2024 (Basic UDI-DI B-08800042100223), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800042100223 Basic UDI-DI 08800042100223UDI-DIDate17 Jun 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
High Intensity Focused Ultrasound
Model / reference
HI-REX, AMI-CL-0841
Primary DI / UDI-DI
08800042100223
Basic UDI-DI
B-08800042100223
EMDN code
Z120610 Ultrasound therapy equipment
Device class
Class IIa
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Lithuania

Manufacturer details

EUDAMED SRN
KR-MF-000017522
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Other properties (12, all answered No)