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Ej-Etl-A1Z

by ELEMENIC CO., Ltd

Ref EJ-ETL-A1ZModel ELEMENT-TL

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8800088900016ETLML Basic UDI-DI 08800088900153UDI-DIDate22 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  • Withdrawn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

Model / Reference
ELEMENT-TL, EJ-ETL-A1Z
Primary DI / UDI-DI
08800088900153
Basic UDI-DI
8800088900016ETLML
EMDN Code
Z120615 Therapeutic lasers
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000038194
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Elemenic Co., Ltd.

Properties

  • Sterile
  • Reusable
  • Measuring Function

Other properties (10)

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