Bladder Scanner
Basic Information
- Primary DI
- 06940912715019
- Basic UDI-DI Code
- B-06940912715019
- Reference
- PBSV5.1
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Mianyang Meike Electronic Equipment Co., Ltd.
Additional Description
Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer. It is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V0399 | MEASUREMENT DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 11898-2018-CE-RGC-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).