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JANUS ProM Hybrid

by PIE Co., Ltd. South Korea EUDAMED

Ref PIE-CA-002Model JANUS ProM Hybrid EMDN Z12021009

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08800274030008HB 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  • Withdrawn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 22 Oct 2026

Model / Reference
JANUS ProM Hybrid, PIE-CA-002
Primary DI / UDI-DI
08800274030008
Basic UDI-DI
08800274030008HB
Direct Marketing DI
08800274030008
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
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

Sources (1)

  • EUDAMED 49c8010c-be03-4aed-bd9c-8cef398e424f 61 fields · synced 22 Oct 2026