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Haclre

by Ami Inc.

Ref AMI-CL-0211Model HACLRE

Haclre (AMI-CL-0211) is a Class IIb device made by Ami Inc., registered in EUDAMED on 12 Jun 2024 (Basic UDI-DI B-08800042100117), 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-08800042100117 Basic UDI-DI 08800042100117UDI-DIDate12 Jun 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Diode Surgical Laser
Model / reference
HACLRE, AMI-CL-0211
Primary DI / UDI-DI
08800042100117
Basic UDI-DI
B-08800042100117
EMDN code
Z12011016 Diode 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
Portugal

Manufacturer details

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

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

Other devices from Ami Inc.

See all devices from Ami Inc. →

Properties

Other properties (12, all answered No)