FDA Registration
Active
🇦🇺 Australia
GO MEDICAL INDUSTRIES PTY. LTD.
Reg #: 9611004
·
FEI: 3002807099
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- GO MEDICAL INDUSTRIES PTY. LTD.
- Registration Number
- 9611004
- FEI Number
- 3002807099
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 200 Churchill Avenue
- City
- SUBIACO Western Australia
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K993651
Owner / Operator
- Firm Name
- GO MEDICAL INDUSTRIES PTY. LTD.
- Operator Number
- 8020024
- Address
- 200 Churchill Ave
- City
- SUBIACO
- State
- Western Australia
- Postal Code
- 6008
- Country
- AU
US Agent
- Business Name
- Compliance Systems International LLC
- Contact Name
- Amanda SINGLETON
- Address
- 39 Lockhart Circle
- City
- Buffalo
- State
- NY
- ZIP
- 14228
- Country
- US
- [email protected]
- Phone
- 716 4407364
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2008-02-04 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2008-02-04 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2011-09-12 |
| Amniotome | HGE | Class 1 | Obstetrics/Gynecology | No | 2008-02-04 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2008-02-04 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2008-02-04 |
Proprietary Names
O'Neil Sterile Field Urinary Catheter
V-Sets
O'Neil Nasal Spray
Amnicot
Catherter, Urological
Springfusor, Flow Control Tubing
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility