FDA Registration Active 🇦🇺 Australia

ATCOR MEDICAL Pty Ltd

Reg #: 9710654 · FEI: 3003339185 · Expires 2026
Products
3
Proprietary Names
7
Establishment Types
2
Classifications
3

Registration Details

Registration Name
ATCOR MEDICAL Pty Ltd
Registration Number
9710654
FEI Number
3003339185
Status
Active
Expiry Year
2026
Initial Importer
No
Address
301/55 Lime Street
City
SYDNEY New South Wales
Country
AU

Regulatory Submissions

510(k) Number
K012487

Owner / Operator

Firm Name
ATCOR MEDICAL Pty Ltd
Operator Number
9048688
Address
301/55 Lime Street
City
Sydney
State
New South Wales
Postal Code
2000
Country
AU
Correspondent
Revathy - Veera Raghavalu

US Agent

Business Name
Atcor Medical
Contact Name
Bob Hayes
Address
Suite 515, 184 Shuman Blvd
City
Naperville
State
IL
ZIP
60563
Country
US
Phone
630 2288876

Products

Device Name Product Code
System, Measurement, Blood-Pressure, Non-Invasive DXN
Computer, Blood-Pressure DSK
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

Proprietary Names

SphygmoCor XCEL SphygmoCor XCEL CP SphygmoCor XCEL PWV SphygmoCor XCEL PWA SphygmoCor XCEL PWA + PWV SphygmoCor XCEL CP + PWV CONNEQT PULSE

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility