FDA Registration Active 🇰🇷 South Korea

POSKOM CO., LTD

Reg #: 3005246977 · FEI: 3005246977 · Expires 2026
Products
2
Proprietary Names
20
Establishment Types
3
Classifications
2

Registration Details

Registration Name
POSKOM CO., LTD
Registration Number
3005246977
FEI Number
3005246977
Status
Active
Expiry Year
2026
Initial Importer
No
Address
POSKOM Tower, 227, Sowon-ro, Deogyang-gu
City
Goyang-si Gyeonggi
Country
KR

Regulatory Submissions

510(k) Number
K253244

Owner / Operator

Firm Name
POSKOM CO., LTD
Operator Number
9053091
Address
POSKOM Tower, 227, Sowon-ro, Deogyang-gu
City
Goyang-si
State
Gyeonggi
Postal Code
10534
Country
KR
Correspondent
Jeonghyun Seong

US Agent

Business Name
PXI MEDICAL
Contact Name
Eugene A Lee
Address
3392 COMMERICAL AVE
City
Northbrook
State
IL
ZIP
60062
Country
US
Phone
847 9711999

Products

Device Name Product Code
System, X-Ray, Mobile IZL
Unit, X-Ray, Extraoral With Timer EHD

Proprietary Names

AirRay-mini 80F AirRay-mini 90F AirRay-mini 90A AirRay-mini 80A AirRay-mini AirRay AirRay-20HL AirRay-20HW AirRay-20HLW AirRay-20H Xcam PXP-100CA Airbile-100 PXM-40BT PLUS PXM-20BT PLUS PXP-60HF PXP-20HF PLUS HUM-20BT(VET-20BT) PXP-40HF REXTAR X

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)