FDA Registration Active 🇨🇦 Canada

DOMREX Sterile Syringe with Needle

Reg #: 3007501254 · FEI: 3007501254 · Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3

Registration Details

Registration Name
DOMREX PHARMA INC.
Registration Number
3007501254
FEI Number
3007501254
Status
Active
Expiry Year
2025
Initial Importer
No
Address
269 rue Robinson
City
Saint-Eustache Quebec
Country
CA

Regulatory Submissions

510(k) Number
K183665

Owner / Operator

Firm Name
DOMREX PHARMA INC.
Operator Number
10078102
Address
269 rue Robinson
City
Saint-Eustache
State
Quebec
Postal Code
J7R 5V7
Country
CA

US Agent

Business Name
Regulatory Insight, Inc.
Contact Name
Kevin Walls
Address
33 Golden Eagle Lane
City
Littleton
State
CO
ZIP
80127
Country
US
Phone
720 9625412

Products

Device Name Product Code
Syringe, Piston FMF
Needle, Hypodermic, Single Lumen FMI
Syringe, Antistick MEG

Proprietary Names

DOMREX Sterile Syringe with Needle DOMREX Sterile Syringe DOMREX Safety Needles DOMREX Sterile Syringe with Safety Needle DOMREX Hypodermic Needle for Single Use

Establishment Types

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