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Mintti

EUDAMED

Class IIa (EU MDR)

Ref smartho-D2

by Suzhou Melodicare Medical Technology Co., Ltd.

Identity

Trade Name
Mintti EUDAMED
Device Name
Electronic Stethoscope EUDAMED
Model / Reference
smartho-D2 EUDAMED

Identifiers

Primary DI / UDI-DI
06973660370001 EUDAMED
Basic UDI-DI
B-06973660370001 EUDAMED
EMDN Code
C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Mintti by Suzhou Melodicare Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000021493
Authorised Representative
Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133

Sources (1)

  • EUDAMED 988fca8f-d476-46b4-81a8-d29956cea609 61 fields · synced Jun 18, 2026