Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

μCor Heart Failure and Arrhythmia Management System (HFAMS)

UDI-DI 00855778005555Basic UDI-DI 0855778005K172510WG

Class IIa · MDR · ZOLL Manufacturing Corporation

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Identification

Model: —
EMDN: Z12050801
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

3903097CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-05-19 · Expiry 2028-09-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

ZOLL Manufacturing Corporation

SRN US-MF-000027987

US · Pittsburgh

manufacturer

Authorised representative: ZOLL International Holding B.V. (NL-AR-000012554)

Related UDI-DIs

μCor Heart Failure and Arrhythmia Management System (HFAMS) 00855778005562
μCor Heart Failure and Arrhythmia Management System (HFAMS) 00855778005609
μCor Heart Failure and Arrhythmia Management System (HFAMS) 00855778005616

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cor-heart-failure-and-arrhythmia-management-system-hfams-5555 · UDI page: /udi/00855778005555

All devices from ZOLL Manufacturing Corporation

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