FDA Registration
Active
🇦🇺 Australia
Planet Innovation Blackburn
Reg #: 3023940736
·
FEI: 3023940736
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Planet Innovation Blackburn
- Registration Number
- 3023940736
- FEI Number
- 3023940736
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 31-47 Joseph Street
- City
- Blackburn North Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K180188
Owner / Operator
- Firm Name
- Planet Innovation
- Operator Number
- 10054268
- Address
- 436 Elgar Road
- City
- Box Hill
- State
- Victoria
- Postal Code
- 3128
- Country
- AU
US Agent
- Business Name
- PLANET INNOVATION
- Contact Name
- Krystal Santiago
- Address
- 80 Technology Drive
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 310 7075882
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2018-11-18 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)