FDA Registration
Active
🇦🇺 Australia
PeriCoach
Reg #: 3030927592
·
FEI: 3030927592
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRATOS MEDTECH PTY LTD
- Registration Number
- 3030927592
- FEI Number
- 3030927592
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 319 Kent Street
- City
- Maryborough Queensland
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K160758
Owner / Operator
- Firm Name
- Stratos MedTech
- Operator Number
- 10046257
- Address
- 319 Kent Street
- City
- Maryborough
- State
- Queensland
- Postal Code
- 4650
- Country
- AU
- Correspondent
- Karien Maskelyne
US Agent
- Business Name
- Pearl Pathways
- Contact Name
- Maritza Ward
- Address
- 29 East McCarty Street, Suite 100
- City
- Indianapolis
- State
- IN
- ZIP
- 46225
- Country
- US
- [email protected]
- Phone
- 317 6026361 ext. 114
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2018-11-28 |
Proprietary Names
PeriCoach
Establishment Types
Manufacture Medical Device