Identity
- Trade Name
- E-CUBE i7 EUDAMEDE-CUBE FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- E-CUBE i7 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800013526007 EUDAMEDFDA UDI
- Basic UDI-DI
- 0880001357300RG EUDAMED
- Direct Marketing DI
- 08800013526007 EUDAMED
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 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 i7 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
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153424 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K182594 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0880001357300RG | Class IIa | Active |
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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 (3)
- EUDAMED a2ea82da-ee44-4f30-9f95-c76d932f2a87 61 fields · synced Oct 6, 2026
- FDA UDI c45bdf91-91e5-4e55-9fea-faff6d57d66d 32 fields · synced May 30, 2026
- FDA 510(k) K153424 1 fields · synced May 18, 2026