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DUOFONO EVOLVE - testa nera - lira nera

EUDAMED

Class I (EU MDR)

Ref 49567Model DUOFONO

by Gima Spa

Identity

Trade Name
DUOFONO EVOLVE - testa nera - lira nera EUDAMED
Device Name
DUOFONO EUDAMED
Model / Reference
DUOFONO EUDAMED
49567 EUDAMED

Identifiers

Primary DI / UDI-DI
08023279495676 EUDAMED
Basic UDI-DI
80232790000C90052600000CH EUDAMED
EMDN Code
C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

DUOFONO EVOLVE - testa nera - lira nera by Gima Spa — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Gima Spa
EUDAMED SRN
IT-MF-000011004

Sources (1)

  • EUDAMED 2fdc70bd-d651-4578-a844-a0a2bf569352 61 fields · synced Jun 18, 2026