FDA Registration Active 🇺🇸 United States

SDX System

Reg #: 3015196842 · FEI: 3015196842 · Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2

Registration Details

Registration Name
DYN'R US Inc.
Registration Number
3015196842
FEI Number
3015196842
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
3363 Ne 163rd St Ste 806e
City
Miami
State
FL
ZIP
33160
Country
US

Regulatory Submissions

510(k) Number
K121845

Owner / Operator

Firm Name
DYN'R US Corp
Operator Number
10057633
Address
3363 NE 163 St, Suite 610
City
Miami
State
FL
Postal Code
33160
Country
US
Correspondent
Gordon Fairbairn

Products

Device Name Product Code
Accelerator, Linear, Medical IYE
System, Radiation Therapy, Charged-Particle, Medical LHN

Proprietary Names

SDX System

Establishment Types

Complaint File Establishment per 21 CFR 820.198