2.0CW Transducer
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 2.0CW Transducer EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- MDR_07_IIA_IQH_BTS LB A_ACDV_CW2_10789380 EUDAMED
- Model / Reference
- 10789380 EUDAMEDFDA UDIMDR_07_IIA_IQH_BTS LB A_ACDV_CW2_10789380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869003795 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686902395W5 EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Extracorporeal ultrasound imaging transducer, hand-held
2.0CW Transducer by Siemens Medical Solutions Usa, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Medical Solutions Usa, Inc.
Sources (2)
- FDA UDI b58f99da-3865-477a-a4d4-6e475065ee35 34 fields · synced Oct 7, 2026
- EUDAMED 76ccee33-ce88-4ba7-83f9-95e836bfcd65 61 fields · synced Oct 7, 2026