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E-Cube 5

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref E-CUBE 5Model E-CUBE

by Alpinion Medical Systems Co., Ltd.

Identity

Trade Name
E-CUBE 5 EUDAMED
E-CUBE FDA UDI
Generic Name
General-purpose ultrasound imaging system FDA UDI
Device Name
E-CUBE 15 EUDAMED
Model / Reference
E-CUBE EUDAMED
E-CUBE 5 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08800013520005 EUDAMEDFDA UDI
Basic UDI-DI
0880001357100R6 EUDAMED
Direct Marketing DI
08800013520005 EUDAMED
FDA Product Code
ITX FDA UDI
IYO FDA UDI
IYN 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
892.1570 FDA UDI
892.1560 FDA UDI
892.1550 FDA UDI
Market of Registration
Germany 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

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

Yes

FDA UDI

E-Cube 5 by Alpinion Medical Systems Co., Ltd. — Class IIa — FDA_510K, MDR — 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/MDR

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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 (4)

  • EUDAMED 7fb78e1c-d2d4-43e3-9ab0-b40930adfda0 61 fields · synced Oct 10, 2026
  • FDA UDI 51659ca7-03f5-4ecd-abc4-1d824d517ce8 32 fields · synced May 30, 2026
  • EUDAMED 3bffc52c-1f07-4330-b9ac-760f152cd645 61 fields · synced Oct 10, 2026
  • FDA 510(k) K142733 1 fields · synced May 18, 2026