FDA Registration Active 🇦🇺 Australia

Philips Sectra MicroDose L30

Reg #: 3008496839 · FEI: 3008496839 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
EvERX PTY LTD
Registration Number
3008496839
FEI Number
3008496839
Status
Active
Expiry Year
2025
Initial Importer
No
Address
3 / 185 Briens Rd, Northmead
City
Sydney New South Wales
Country
AU

Regulatory Submissions

510(k) Number
K110025

Owner / Operator

Firm Name
EverX / Bindra
Operator Number
10033159
Address
3 / 185 Briens Rd, Northmead
City
Sydney
State
New South Wales
Postal Code
2152
Country
AU
Correspondent
Ravinder S Bindra

US Agent

Business Name
EverX USA LLC
Contact Name
Hamish Dunn
Address
2410 LA MIRADA DRIVE
City
Vista
State
CA
ZIP
92081
Country
US
Phone
760 4297019

Products

Device Name Product Code
Full Field Digital, System, X-Ray, Mammographic MUE

Proprietary Names

Philips Sectra MicroDose L30

Establishment Types

Export Device to the United States But Perform No Other Operation on Device