CUBEScan

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref BioCon-900S510(k) K200749

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
CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides cross–sectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module. FDA UDI
Model / Reference: BioCon-900S EUDAMEDFDA UDI
Description: CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides cross–sectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809458500085 EUDAMEDFDA UDI
Basic UDI-DI: B-08809458500085 EUDAMED
510(k) Number: K200749 FDA UDI
FDA Product Code: IYO FDA UDI
ITX FDA UDI
EMDN Code: Z12080304 ULTRASONIC BLADDER VOLUME SCANNERS EUDAMED
GMDN Term: Bladder volume ultrasound imaging system FDA UDI

Classification

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

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

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

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

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K200749	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-08809458500085	Class IIa	Active

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Manufacturer

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

Sources (3)

EUDAMED b4e828ec-666c-45b9-8dfd-e588c2ffa3c6 85 fields · synced Jun 18, 2026
FDA UDI 7088dda5-103a-4372-a4eb-a020c91cadfe 35 fields · synced May 30, 2026
FDA 510(k) K200749 1 fields · synced May 18, 2026