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Iris

by BLUECORE COMPANY CO., Ltd.

Ref IRIS

Active European Union

CE MDD

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/MDD NumberB-088001011000039W Basic UDI-DI D-088001011000039WUDI-DIDate8 Sep 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Q-Switched Nd:YAG Laser
Model / Reference
IRIS
Primary DI / UDI-DI
D-088001011000039W
Basic UDI-DI
B-088001011000039W
EMDN Code
Z12011017 Neodymium surgical laser
Device Class
Class IIb
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000038537
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from BLUECORE COMPANY Co., Ltd.

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    Class II

  • Lasya-Trinity

    Class II

  • Bm.iris

    Class II

  • ZenPro 40

    Class II

Properties

  • Reprocessed

Other properties (10)

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