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BX300

by Ami Inc.

Ref AMI-CL-0531Model BX300

BX300 (AMI-CL-0531) is a Class IIb device made by Ami Inc., registered in EUDAMED on 14 Jun 2024 (Basic UDI-DI B-08800042100155), 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-08800042100155 Basic UDI-DI 08800042100155UDI-DIDate14 Jun 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Fractional CO2 Laser
Model / reference
BX300, AMI-CL-0531
Primary DI / UDI-DI
08800042100155
Basic UDI-DI
B-08800042100155
EMDN code
Z12011005 Carbon dioxide surgical laser
Device class
Class IIb
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Poland

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)