FDA Registration Active 🇦🇺 Australia

Khelix

Reg #: 3009337690 · FEI: 3009337690 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
SABRE MEDICAL PTY LTD
Registration Number
3009337690
FEI Number
3009337690
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Unit 1, 9 Chaplin Drive
City
Lane Cove West New South Wales
Country
AU

Regulatory Submissions

510(k) Number
K211327

Owner / Operator

Firm Name
Sabre Medical Pty Ltd
Operator Number
10052921
Address
Unit 1, 9 Chaplin Drive
City
Lane Cove West
State
New South Wales
Postal Code
2066
Country
AU

US Agent

Business Name
Emergo Global Representation LLC
Contact Name
Yong Sun
Address
2500 Bee Cave Rd., Bldg. 1, Ste. 300
City
Austin
State
TX
ZIP
78746
Country
US
Phone
512 3279997

Products

Device Name Product Code
Catheter, Electrode Recording, Or Probe, Electrode Recording DRF

Proprietary Names

Khelix

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)