Identity
- Trade Name
- CUBEScan EUDAMEDFDA UDI
- Generic Name
- Bladder volume ultrasound imaging system FDA UDI
- Device Name
- Bladder Volume Measurement System EUDAMEDCUBEScan BioCon-900 (bladder volume measurement system) is a safe and easy, noninvasive system to measure the bladder volume. CUBEScan BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during Pre-scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to input the patient information, print measurements, export to pdf or jpg, archive data, and review data. FDA UDI
- Model / Reference
- BioCon-900 EUDAMEDFDA UDI
- Description
- CUBEScan BioCon-900 (bladder volume measurement system) is a safe and easy, noninvasive system to measure the bladder volume. CUBEScan BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore, a live image of the bladder during Pre-scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to input the patient information, print measurements, export to pdf or jpg, archive data, and review data. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809458500009 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809458500009 EUDAMED
- 510(k) Number
- K171591 FDA UDI
- 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
- 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
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-08809458500009 | 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 507b8712-a60f-4d3d-be23-d55e9116845d 61 fields · synced May 30, 2026
- FDA UDI d0ba5092-015e-49fa-bfd8-771b4d3813d7 35 fields · synced May 30, 2026