Electrocardiograph

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED

Ref BeneHeart R12AModel BeneHeart R12/BeneHeart R12B/BeneHeart R12A/BeneHeart R3/BeneHeart R3B/BeneHeart R3A

EMDN Z12050301

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69449040AB010000563R Basic UDI-DI	Date29 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: BeneHeart R12/BeneHeart R12B/BeneHeart R12A/BeneHeart R3/BeneHeart R3B/BeneHeart R3A, BeneHeart R12A

Primary DI / UDI-DI: 06944904051932
Basic UDI-DI: 69449040AB010000563R
EMDN Code: Z12050301 General purpose electrocardiographs

Device Class: Class IIa
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014156
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records

Measuring Function

Other properties (12)

Sterile: 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
Incorporates Medicinal Product: No

Sources (1)

EUDAMED 994d74ab-d165-46c7-965b-e2406d530981 61 fields · synced 24 Oct 2026