FDA Registration
Active
🇩🇪 Germany
DxFLEX Sheath Fluid
Reg #: 3002721051
·
FEI: 3002721051
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Beckman Coulter GmbH
- Registration Number
- 3002721051
- FEI Number
- 3002721051
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Europark Fichtenhain B 13
- City
- Krefeld North Rhine-Westphalia
- Country
- DE
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- David G Davis
US Agent
- Business Name
- Beckman Coulter, Inc.
- Contact Name
- David Davis
- Address
- 250 S. Kraemer Blvd
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 469 2368180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 1977-12-14 |
Proprietary Names
DxFLEX Sheath Fluid
ISOFLOW Sheath Fluid
AQUIOS Sheath Solution
AcT 5diff Diluent
DxH 500 Series Diluent (PN B36845)
DxH Diluent
DxH ECO Diluent
DxH Concentrated ECO Diluent
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)