Identity
- Trade Name
- CUBEScan EUDAMEDFDA UDI
- Generic Name
- Bladder volume ultrasound imaging system FDA UDI
- Device Name
- Bladder Volume Measurement System EUDAMEDThe BioCon-500 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-500 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-500 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-500 EUDAMEDFDA UDI
- Description
- The BioCon-500 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-500 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-500 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
- 08809458500023 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809458500023 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- EMDN Code
- Z12080304 ULTRASONIC BLADDER VOLUME SCANNERS EUDAMED
- GMDN Term
- Bladder volume ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI
- 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
EUDAMED
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 — 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-08809458500023 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 069f8540-8504-4870-b9e0-448b2432d5c1 61 fields · synced May 31, 2026
- FDA UDI 3ca243c5-39f3-4f60-8605-a4582f88e6b2 33 fields · synced May 27, 2026