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JANUS ProM Sunlike

by PIE Co., Ltd. South Korea EUDAMED

Ref PIE-CA-001Model JANUS ProM Sunlike EMDN Z12021009

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08800274030015H8 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
JANUS ProM Sunlike
Model / Reference
JANUS ProM Sunlike, PIE-CA-001
Primary DI / UDI-DI
08800274030015
Basic UDI-DI
08800274030015H8
Direct Marketing DI
08800274030015
EMDN Code
Z12021009 Direct outpatient video-otoscopes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000044396
Authorised representative
SMGeurope OÜ EE-AR-000048466

Other devices from PIE Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
Other properties (12)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 86fce4a5-2d6b-4fc2-a6eb-cdb013d30843 61 fields · synced 23 Oct 2026