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Palm Bladder Scanner

FDA UDI

Class II (US FDA UDI)

by Mianyang Meike Electronic Equipment Co., Ltd.

Identity

Trade Name
Palm Bladder Scanner FDA UDI
Generic Name
Hand-held ultrasound imaging system, body-surface FDA UDI
Device Name
Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface. FDA UDI
Model / Reference
PBSV7.1 FDA UDI
Description
Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface. FDA UDI

Identifiers

Primary DI / UDI-DI
06940912716016 FDA UDI
FDA Product Code
IYO FDA UDI
ITX FDA UDI
GMDN Term
Hand-held ultrasound imaging system, body-surface FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1570 FDA UDI
Commercial Distribution
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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held ultrasound imaging system, body-surface

Palm Bladder Scanner by Mianyang Meike Electronic Equipment Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held ultrasound imaging system, body-surface.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mianyang Meike Electronic Equipment Co., Ltd.

Sources (1)

  • FDA UDI a06215ab-c70e-4b10-a56d-58a6fcc29fe2 33 fields · synced May 30, 2026