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CUBEScan

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref BioCon-700Ref BioCon-2000W

by Mcube Technology Co., Ltd

Identity

Trade Name
CUBEScan EUDAMEDFDA UDI
Generic Name
Bladder volume ultrasound imaging system FDA UDI
Device Name
Bladder Volume Measurement System EUDAMED
Magnetic Incontinence Therapy System EUDAMED
The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-700 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results. FDA UDI
Model / Reference
BioCon-700 EUDAMEDFDA UDI
BioCon-2000W EUDAMED
Description
The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-700 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results. FDA UDI

Identifiers

Primary DI / UDI-DI
08809458500016 EUDAMEDFDA UDI
08809458500054 EUDAMED
Basic UDI-DI
B-08809458500016 EUDAMED
B-08809458500054 EUDAMED
FDA Product Code
ITX FDA UDI
IYO FDA UDI
EMDN Code
Z12080304 ULTRASONIC BLADDER VOLUME SCANNERS EUDAMED
Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
GMDN Term
Bladder volume ultrasound imaging system 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
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMEDEUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

CUBEScan by Mcube Technology Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Mcube Technology Co., Ltd
EUDAMED SRN
KR-MF-000020590
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (4)

  • EUDAMED f3aefb4b-7be9-4781-ae4c-0a2c1646111d 61 fields · synced Aug 2, 2026
  • EUDAMED 64d9fff2-ce15-4787-bfb2-048ece768b0b 61 fields · synced May 18, 2026
  • FDA UDI 9edff621-7e8e-42b5-86c8-6a8600e780c7 34 fields · synced May 30, 2026
  • FDA 510(k) K111021 1 fields · synced May 18, 2026