Identity
- Trade Name
- C613 EUDAMEDSonoScape FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Ultrasonic Transducer EUDAMEDC613 Ultrasonic Transducer (S9) FDA UDI
- Model / Reference
- C613 EUDAMEDFDA UDI/ EUDAMED
- Description
- C613 Ultrasonic Transducer (S9) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868601553 EUDAMEDFDA UDI
- Basic UDI-DI
- 69458686P1007QW EUDAMED
- Direct Marketing DI
- 06945868601553 EUDAMED
- 510(k) Number
- K152165 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) 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 UDI892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- Netherlands 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
C613 by Sonoscape Medical Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69458686P1007QW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED afa8a10d-182e-4cbe-bafb-045707a18a3d 61 fields · synced Oct 7, 2026
- FDA UDI d9bfcc5e-721f-4220-9c8a-919c6e11dcd5 34 fields · synced May 29, 2026