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MiroCam Capsule Endoscope System

by IntroMedic Co., Ltd. 6 variants

Ref MiroView 4.0

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809260260788 Basic UDI-DI 08809260260788UDI-DIDate2 Oct 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  • Withdrawn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
MiroCam Capsule Endoscope System
Model / Reference
MiroView 4.0
Primary DI / UDI-DI
08809260260788
Basic UDI-DI
B-08809260260788
EMDN Code
Z12021292 Endoscopic capsule signal receivers - medical device software
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
KR-MF-000024897
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from IntroMedic Co., LTD.

See all devices from IntroMedic Co., LTD. →

Properties

Other properties (11)

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