# ALPINION MEDICAL SYSTEMS Co., Ltd.

FEI: 3008950127
Status: Active
Establishment types: Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Owner/operator: Alpinion Medical Systems Co., Ltd. (#10037469)

Address: 4F, 15, Magokjungang 14-ro, Gangseo-gu Seoul, 07789, KR

Mandatory US Agent: ALPINION USA

## Products

Total registered: 3
Top product codes: IYN, IYO, ITX
Regulation §: 892.1550, 892.1560, 892.1570

Proprietary names: L3-12HWD, SP3-8T, L8-17H, SP1-5T, IO8-17T, L3-12T, EV3-10T, E-CUBE i7, L3-8H, VC1-6T

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223008950127%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3008950127