FDA Registration
Active
🇩🇪 Germany
AXINON® LDL-p Test System
Reg #: 3011080315
·
FEI: 3011080315
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NUMARES AG
- Registration Number
- 3011080315
- FEI Number
- 3011080315
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Am BioPark 13
- City
- Regensburg Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K210801
Owner / Operator
- Firm Name
- Numares AG
- Operator Number
- 10088504
- Address
- Am BioPark 13
- City
- Regensburg
- State
- Bavaria
- Postal Code
- 93053
- Country
- DE
- Correspondent
- Stefanie Dukorn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2023-08-04 |
Proprietary Names
AXINON® LDL-p Test System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device