FDA Registration Active 🇺🇸 United States

ALPINION USA

Reg #: 3009293490 · FEI: 3009293490 · Expires 2026
Products
3
Proprietary Names
9
Establishment Types
1
Classifications
3

Registration Details

Registration Name
ALPINION USA
Registration Number
3009293490
FEI Number
3009293490
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
21222 30th Dr SE Ste C-122
City
Bothell
State
WA
ZIP
98021
Country
US

Regulatory Submissions

510(k) Number
K150773

Owner / Operator

Firm Name
Alpinion USA
Operator Number
10042979
Address
21222 30th Dr. SE, Ste C-122
City
Bothell
State
WA
Postal Code
98021
Country
US
Correspondent
Gene Kim

Products

Device Name Product Code
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO

Proprietary Names

E-Cube 15 E-Cube 11 E-Cube 5 E-Cube i7 E-Cube Inno E-Cube 9 E-Cube 7 E-Cube 8 E-Cube 12

Establishment Types

Repack or Relabel Medical Device