FDA Registration
Active
🇨🇷 Costa Rica
Low Pressure Connector Tubing
Reg #: 3011334555
·
FEI: 3011334555
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Bayer Medical SRL
- Registration Number
- 3011334555
- FEI Number
- 3011334555
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Block B Lot 1, Metro Park
- City
- Barreal de Heredia
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K831188
Owner / Operator
- Firm Name
- Bayer Medical Care Inc.
- Operator Number
- 2520313
- Address
- 1 Bayer Drive
- City
- Indianola
- State
- PA
- Postal Code
- 15051
- Country
- US
- Correspondent
- Troy A Jack
US Agent
- Business Name
- Bayer Medical Care, Inc.
- Contact Name
- Troy Jack
- Address
- 1 Bayer Drive
- City
- Indianola
- State
- PA
- ZIP
- 15051
- Country
- US
- [email protected]
- Phone
- 412 3528280
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | DOY | Class 2 | Clinical Toxicology | No | 2014-08-13 |
Proprietary Names
Low Pressure Connector Tubing
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)