Identity
- Trade Name
- BCL10-5 EUDAMEDSonoScape FDA UDI
- Generic Name
- Rectal ultrasound imaging system transducer FDA UDI
- Device Name
- Ultrasonic Transducer EUDAMEDBCL10-5 Ultrasonic Transducer (S40) FDA UDI
- Model / Reference
- BCL10-5 EUDAMEDFDA UDI/ EUDAMED- EUDAMED
- Description
- BCL10-5 Ultrasonic Transducer (S40) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868600464 EUDAMEDFDA UDI06945868608439 EUDAMED06945868610593 EUDAMED
- Basic UDI-DI
- 69458686P1014QT EUDAMED
- Direct Marketing DI
- 06945868600464 EUDAMED06945868608439 EUDAMED06945868610593 EUDAMED
- 510(k) Number
- K152854 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Rectal ultrasound imaging system transducer 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Bcl10-5 by Sonoscape Medical Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69458686P1014QT | 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 (4)
- EUDAMED fe9da819-e555-4deb-a1ef-c0f0e7aa9a25 61 fields · synced Oct 6, 2026
- EUDAMED 65342fc2-d6bc-4b01-ada5-dea1e2caea23 61 fields · synced May 17, 2026
- EUDAMED f0f93795-8fa9-448e-8b0d-bef0ff00772f 61 fields · synced May 19, 2026
- FDA UDI fe11f8e7-d293-4f24-b78c-cad5968c962d 34 fields · synced May 30, 2026