FDA Registration
Active
🇦🇺 Australia
VorOtek O Scope
Reg #: 3007739031
·
FEI: 3007739031
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- VOROTEK
- Registration Number
- 3007739031
- FEI Number
- 3007739031
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 23 Point Henry Road
- City
- Moolap Victoria
- Country
- AU
Owner / Operator
- Firm Name
- VorOtek
- Operator Number
- 10050112
- Address
- 23 Point Henry Road, 23 Point Henry Road
- City
- Moolap
- State
- Victoria
- Postal Code
- 3224
- Country
- AU
- Correspondent
- Charles Vorrath
US Agent
- Business Name
- Black & Black Surgical, Inc.
- Contact Name
- Norman Black
- Address
- 5175 South Royal Atlanta Drive
- City
- Tucker
- State
- GA
- ZIP
- 30084
- Country
- US
- [email protected]
- Phone
- 770 4144880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2015-10-13 |
Proprietary Names
VorOtek O Scope
VorOtek V Scope
VorOtek M Scope
VorOtek L Scope
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device