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Catalys Precision Laser System

by AMO Manufacturing USA, LLC

Ref 0160-6010

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5050474a000089G Basic UDI-DI 05050474617179UDI-DIDate26 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Catalys System
Model / Reference
0160-6010
Primary DI / UDI-DI
05050474617179
Basic UDI-DI
5050474a000089G
Direct Marketing DI
05050474617179
EMDN Code
Z12120299 Therapeutic and surgical ophtholmological treatments instruments - other
Device Class
Class IIb
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000023322
Authorised representative
AMO Ireland IE-AR-000013513

Other devices from AMO Manufacturing USA, LLC

See all devices from AMO Manufacturing USA, LLC →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No