Identity
- Trade Name
- Bladder Scanner FDA UDI
- Generic Name
- Bladder volume ultrasound imaging system FDA UDI
- Device Name
- The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. FDA UDI
- Model / Reference
- M4-HD FDA UDI
- Description
- The M Series Bladder Scanner provides non-invasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972608310086 FDA UDI
- 510(k) Number
- K190769 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDI
- GMDN Term
- Bladder volume ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bladder Scanner by Suzhou Lischka Medtech Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suzhou Lischka Medtech Co., Ltd
Sources (1)
- FDA UDI daf90b77-5f9e-480f-8688-6b2c5abe1e3c 35 fields · synced May 30, 2026