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exciplex

by Clarteis SAS

Ref EIPL-100

exciplex (EIPL-100) is a Class IIb device made by Clarteis, registered in EUDAMED on 18 May 2026 (Basic UDI-DI 376031346EIPL-100DB) with CE/MDR certificate MDR 00135-A valid until 23 Nov 2030, active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

23 Nov 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376031346EIPL-100DB Basic UDI-DI 03760313460065UDI-DIDate18 May 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00135-A Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    24 Nov 2025
    Expires
    23 Nov 2030

Timeline

3 dated events

  1. Certificate issued EUDAMED MDR 00135-A
  2. Registered EUDAMED 376031346EIPL-100DB
  3. Certificate expires EUDAMED MDR 00135-A

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
exciplex
Model / reference
EIPL-100
Primary DI / UDI-DI
03760313460065
Basic UDI-DI
376031346EIPL-100DB
Direct marketing DI
03760313460065
EMDN code
Z12040202 Phototherapy equipment
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
FR-MF-000002542

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Properties

Other properties (14, all answered No)