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Sw Hmsc 3.68 532426

by BIOTRONIK SE & Co. KG EUDAMEDGUDID

Active European Union

Ref 532426Model HMSC

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04035479194406 UDI-DIDate9 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4035479BUDI00002PN Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • G70 010275 0541 Active Reissued

    Technical documentation EU MDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    6 May 2026
    Expires
    5 Aug 2031
    Valid from
    6 Aug 2026
  • G70 010275 0541 Expired

    Technical documentation EU MDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    21 Jan 2022
    Expires
    5 Aug 2026

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Sw Hmsc 3.68
Generic Name
Implantable cardiac device management application software
Model / Ref / Catalog
532426, HMSC
Primary DI / UDI-DI
04035479194406
Basic UDI-DI
4035479BUDI00002PN
Direct Marketing DI
04035479194406
FDA Product Code
OSR
EMDN Code
J010792 Active implantable cardiac devices remote monitoring systems - medical device software
GMDN Term
Implantable cardiac device management application software
Device Class
Class III
Special Device Type
Software
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Other devices from BIOTRONIK SE & Co. KG

See all devices from BIOTRONIK SE & Co. KG →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No