FDA Registration
Active
🇩🇪 Germany
HUMANOPTICS HOLDING AG
Reg #: 3010531293
·
FEI: 3010531293
·
Expires 2026
Products
1
Proprietary Names
23
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HUMANOPTICS HOLDING AG
- Registration Number
- 3010531293
- FEI Number
- 3010531293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Westerwaldstr. 11-13
- City
- Sankt Augustin North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- PMA Number
- P170039
Owner / Operator
- Firm Name
- HumanOptics Holding AG
- Operator Number
- 10058390
- Address
- Westerwaldstr. 11-13
- City
- Sankt Augustin
- State
- North Rhine-Westphalia
- Postal Code
- 53757
- Country
- DE
- Correspondent
- Alexander Burka
US Agent
- Business Name
- Clinical Research Consultants, Inc.
- Contact Name
- Barbara Fant
- Address
- 3928 North Cliff Lane
- City
- Cincinnati
- State
- OH
- ZIP
- 45220
- Country
- US
- [email protected]
- Phone
- 513 6073932
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Artificial Iris | QBT | Class 3 | Unknown | No | 2018-09-10 |
Proprietary Names
ARTIFICIALIRIS FiberFree SELECT Light Green
ARTIFICIALIRIS FiberFree SELECT Light Brown
ARTIFICIALIRIS FiberFree SELECT Medium Brown
ARTIFICIALIRIS with Fiber STANDARD Black
ARTIFICIALIRIS FiberFree SELECT Dark Green
ARTIFICIALIRIS with Fiber CUSTOMFLEX®
ARTIFICIALIRIS with Fiber SELECT Light Blue
ARTIFICIALIRIS FiberFree CUSTOMFLEX®
ARTIFICIALIRIS FiberFree SELECT Dark Brown
ARTIFICIALIRIS with Fiber SELECT Dark Blue
ARTIFICIALIRIS FiberFree STANDARD Black
ARTIFICIALIRIS FiberFree SELECT Medium Blue
CUSTOMFLEX ARTIFICIAL IRIS
ARTIFICIALIRIS with Fiber SELECT Dark Green
ARTIFICIALIRIS FiberFree SELECT Dark Blue
ARTIFICIALIRIS with Fiber SELECT Medium Brown
ARTIFICIALIRIS with Fiber SELECT Light Green
ARTIFICIALIRIS FiberFree SELECT Light Blue
ARTIFICIALIRIS with Fiber SELECT Dark Brown
ARTIFICIALIRIS with Fiber SELECT Medium Blue
ARTIFICIALIRIS with Fiber SELECT Light Brown
ARTIFICIALIRIS FiberFree SELECT Medium Green
ARTIFICIALIRIS with Fiber SELECT Medium Green
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)