FDA Registration
Active
🇦🇺 Australia
Steritech
Reg #: 3002808271
·
FEI: 3002808271
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Steritech
- Registration Number
- 3002808271
- FEI Number
- 3002808271
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 160 South Gippsland Highway
- City
- Dandenong Victoria
- Country
- AU
Owner / Operator
- Firm Name
- Steritech
- Operator Number
- 10077638
- Address
- 5-7 Widemere Road
- City
- Wetherill Park
- State
- New South Wales
- Postal Code
- 2164
- Country
- AU
- Correspondent
- Joseph Azary
US Agent
- Business Name
- Aztech Regulatory and Quality LLC
- Contact Name
- Joseph Azary
- Address
- 543 Long Hill Ave
- City
- Shelton
- State
- CT
- ZIP
- 06484
- Country
- US
- [email protected]
- Phone
- 203 2426670
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | Class U | Unknown | No | 2024-05-15 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2025-04-04 |
| Instrument, Biopsy, Suction | FCK | Class 2 | Gastroenterology, Urology | No | 2020-09-11 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2022-08-16 |
Proprietary Names
NovoSorb ® BTM
Remplir, MODEL ON-152, ON-203, ON-304, ON-405
RB12 Suction Rectal Biopsy System
NovoSorb ® MTX
Striate+, MODEL OCG-152, OCG-203, OCG-304, OCG-405
perFORM, MODEL perf1520, perf2030, perf3040
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)