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Sign in to claim this brandSuzhou PeakSonic Medical Technology Co., LTD.
US
Last updated May 30, 2026
What Suzhou PeakSonic Medical Technology Co., LTD. makes
The company manufactures bladder volume ultrasound imaging systems designed for non-invasive measurement of residual urine volume in the bladder. These devices are portable and intended for clinical use to assess urinary retention or post-voiding residual urine.
The portfolio consists of Class II devices listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Suzhou PeakSonic Medical Technology Co., LTD. manufacture?
Suzhou PeakSonic Medical Technology Co., LTD. specializes in bladder volume ultrasound imaging systems. These devices are designed for non-invasive measurement of residual urine volume in the bladder, helping clinicians assess urinary retention or post-voiding residual urine. The systems are portable and intended for clinical use.
Where is Suzhou PeakSonic Medical Technology Co., LTD. based?
The company is based in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs the classification and listing of its devices.
Which regulatory registries list the devices manufactured by Suzhou PeakSonic Medical Technology Co., LTD.?
The devices produced by Suzhou PeakSonic Medical Technology Co., LTD. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States.
How are the devices manufactured by Suzhou PeakSonic Medical Technology Co., LTD. classified?
The devices manufactured by Suzhou PeakSonic Medical Technology Co., LTD. fall under Class II classification. This classification is assigned based on the level of risk associated with the device, where Class II devices generally pose moderate risk and require special controls to ensure their safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 554531949
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bladder Scanner | M3 | FDA UDI | Class II | Active |
| Bladder Scanner | M4 | FDA UDI | Class II | Active |
| Bladder Scanner | M5 | FDA UDI | Class II | Active |
| Bladder Scanner | M2-W | FDA UDI | Class II | Active |
| Bladder Scanner | M2 | FDA UDI | Class II | Active |
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