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1797/R

by FIAB S.p.A.

Ref 1797/RModel Dual-chamber external cardiac stimulator

1797/R is a Class III device made by FIAB S.p.A., registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI 803300326005000001LE), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

26 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803300326005000001LE Basic UDI-DI 08058480753963UDI-DIDate29 Jul 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 823996 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    27 May 2026
    Expires
    26 Mar 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
Dual-chamber external cardiac stimulator, 1797/R
Primary DI / UDI-DI
08058480753963
Basic UDI-DI
803300326005000001LE
Direct marketing DI
08058480753963
EMDN code
Z12050602 Invasive cardiac stimulators
Device class
Class III
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000005988

Similar devices in this category

Other devices filed under CARDIOLOGY AND CARDIOSURGERY INSTRUMENTS.

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Properties

Other properties (14, all answered No)