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SOUND REACH FSW Footswitch
EUDAMEDClass IIb (EU MDR)
Ref FSW2Model CSUS8000, Accessories: TRA6, FSW2
Identity
- Trade Name
- SOUND REACH FSW Footswitch EUDAMED
- Device Name
- Ultrasound Surgical Equipment, Accessories: Transducer of Ultrasound Surgical Equipment,Footswitch of Ultrasound Surgical Equipment EUDAMED
- Model / Reference
- CSUS8000, Accessories: TRA6, FSW2 EUDAMEDFSW2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953815802304 EUDAMED
- Basic UDI-DI
- 69538158F100PH 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
SOUND REACH FSW Footswitch by Reach Surgical, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69538158F100PH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Reach Surgical, Inc.
- EUDAMED SRN
- CN-MF-000011148
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 43c52360-4e33-4df4-bf84-b85ba5102dd9 61 fields · synced Oct 6, 2026