Bladder Scanner

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref PBSV4.1

by Mianyang Meike Electronic Equipment Co., Ltd.

Identity

Trade Name: Bladder Scanner EUDAMEDFDA UDI
Generic Name: Hand-held ultrasound imaging system, body-surface FDA UDI
Device Name: Bladder Scanner EUDAMED
PBS V4.1 Bladder Scanner 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 thle 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 contraindlicated 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 wotund and skin disease. FDA UDI
Model / Reference: PBSV4.1 EUDAMED
PBS V4.1 FDA UDI
Description: PBS V4.1 Bladder Scanner 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 thle 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 contraindlicated 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 wotund and skin disease. FDA UDI

Identifiers

Primary DI / UDI-DI: 06940912714012 EUDAMEDFDA UDI
Basic UDI-DI: B-06940912714012 EUDAMED
510(k) Number: K130229 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
EMDN Code: V0399 MEASUREMENT DEVICES - OTHER EUDAMED
GMDN Term: Hand-held ultrasound imaging system, body-surface FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
Market of Registration: Norway EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06940912714012	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Mianyang Meike Electronic Equipment Co., Ltd.
EUDAMED SRN: CN-MF-000002172
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (2)

EUDAMED 5d8fdd5b-a688-4b7d-93bf-1c4c926ad2a8 61 fields · synced Jun 8, 2026
FDA UDI fce59f47-421c-490b-b06b-4d469a71d0dd 34 fields · synced May 30, 2026