FDA Registration
Active
🇩🇪 Germany
MeMed BV
Reg #: 3006165521
·
FEI: 3006165521
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MICROCOAT BIOTECHNOLOGIE GMBH
- Registration Number
- 3006165521
- FEI Number
- 3006165521
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Am Neuland 3
- City
- Bernried Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K230944
Owner / Operator
- Firm Name
- Microcoat Biotechnologie GmbH
- Operator Number
- 10082962
- Address
- Am Neuland 3
- City
- Bernried
- State
- Bavaria
- Postal Code
- 82347
- Country
- DE
- Correspondent
- Yvonne Kerwitz
US Agent
- Business Name
- NAMSA
- Contact Name
- Adrian Keene
- Address
- 6750 Wales Rd
- City
- Northwood
- State
- OH
- ZIP
- 43619
- Country
- US
- [email protected]
- Phone
- 419 6668455
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunoassay For Host Biomarkers Of Infection | QPS | Class 2 | Microbiology | No | 2023-07-12 |
Proprietary Names
MeMed BV
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)