X-Cube 50

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref X-CUBE 50Model X-CUBE

by Alpinion Medical Systems Co., Ltd.

Identity

Trade Name: X-CUBE 50 EUDAMEDFDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: X-CUBE 90 EUDAMED
The X-CUBE 50 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 50 is intended to be used in a hospital or medical clinic. FDA UDI
Model / Reference: X-CUBE EUDAMED
X-CUBE 50 EUDAMEDFDA UDI
Description: The X-CUBE 50 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 50 is intended to be used in a hospital or medical clinic. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800013544001 EUDAMEDFDA UDI
Basic UDI-DI: 0880001357000QZ EUDAMED
Direct Marketing DI: 08800013544001 EUDAMED
FDA Product Code: IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
EMDN Code: Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
892.1550 FDA UDI
892.1570 FDA UDI
Market of Registration: Poland 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

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

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

X-Cube 50 by Alpinion Medical Systems Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0880001357000QZ	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Alpinion Medical Systems Co., Ltd.
EUDAMED SRN: KR-MF-000012961
Authorised Representative: Alpinion Medical Deutschland GmbH DE-AR-000008603

Sources (2)

EUDAMED d175a9b4-b627-4a3f-900e-bb9cb9d7084a 61 fields · synced Oct 6, 2026
FDA UDI 0bfc8fc4-1aa3-4375-bd34-7bf4311d1b6b 33 fields · synced May 30, 2026