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Touchscreen paysage + SD

EUDAMED

Class IIa (EU MDR)

Ref 1503105-005Model INTEGRABLE DEVICES

by Bien-Air Dental SA

Identity

Trade Name
Touchscreen paysage + SD EUDAMED
Device Name
INTEGRABLE DEVICES EUDAMED
Model / Reference
INTEGRABLE DEVICES EUDAMED
1503105-005 EUDAMED

Identifiers

Primary DI / UDI-DI
J00715031050051 EUDAMED
Basic UDI-DI
++J007IOPT0001YC EUDAMED
Direct Marketing DI
J00715031050051 EUDAMED
EMDN Code
Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Austria 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

Touchscreen paysage + SD by Bien-Air Dental SA — Class IIa — 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
Bien-Air Dental SA
EUDAMED SRN
CH-MF-000014661
Authorised Representative
Bien-Air Europe Sàrl FR-AR-000011942

Sources (1)

  • EUDAMED ebd4040d-1688-47a8-a9df-87f8e95123b0 61 fields · synced Jul 18, 2026