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D500

by Mediana Co., Ltd 17 variants

Ref D500M-0HModel D500

D500 (D500M-0H) is a Class IIb device made by Mediana Co., Ltd., registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-18800003456861), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-18800003456861 Basic UDI-DI 18800003456861UDI-DIDate14 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Defibrillator/Monitor
Model / reference
D500, D500M-0H
Primary DI / UDI-DI
18800003456861
Basic UDI-DI
B-18800003456861
EMDN code
Z12030502 Manual defibrillators
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
KR-MF-000026570
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under MANUAL DEFIBRILLATORS.

Other devices from Mediana Co., Ltd.

See all devices from Mediana Co., Ltd. →

Properties

  • Measuring function
Other properties (11, all answered No)