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SOUND REACH CSUS8000 Generator

EUDAMED

Class IIb (EU MDR)

Ref CSUS8000Model CSUS8000, Accessories: TRA6, FSW2

by Reach Surgical, Inc.

Identity

Trade Name
SOUND REACH CSUS8000 Generator EUDAMED
Device Name
Ultrasound Surgical Equipment, Accessories: Transducer of Ultrasound Surgical Equipment,Footswitch of Ultrasound Surgical Equipment EUDAMED
Model / Reference
CSUS8000, Accessories: TRA6, FSW2 EUDAMED
CSUS8000 EUDAMED

Identifiers

Primary DI / UDI-DI
06953815802298 EUDAMED
Basic UDI-DI
69538158F100PH EUDAMED
Direct Marketing DI
06953815802298 EUDAMED
EMDN Code
Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Category: Ultrasonic surgical system generator

SOUND REACH CSUS8000 Generator by Reach Surgical, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic surgical system generator.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Reach Surgical, Inc.
EUDAMED SRN
CN-MF-000011148
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED a38426f3-69fc-40f7-bb01-9c98925c634f 61 fields · synced Jul 9, 2026