FDA Registration
Active
🇦🇺 Australia
Integre
Reg #: 3013515803
·
FEI: 3002806902
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ellex Medical Pty Ltd
- Registration Number
- 3013515803
- FEI Number
- 3002806902
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3-4 Second Avenue
- City
- Mawson Lakes South Australia
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K041598
Owner / Operator
- Firm Name
- Ellex Medical
- Operator Number
- 9010469
- Address
- 3-4 Second Avenue, --
- City
- Mawson Lakes
- State
- South Australia
- Postal Code
- 5095
- Country
- AU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2008-11-11 |
Proprietary Names
Integre
Solitaire
Establishment Types
Complaint File Establishment per 21 CFR 820.198