FDA Registration
Active
🇫🇷 France
NORMAND-INFO S.A.S.U.
Reg #: 3006543086
·
FEI: 3006543086
·
Expires 2026
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NORMAND-INFO S.A.S.U.
- Registration Number
- 3006543086
- FEI Number
- 3006543086
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7 rue Frederic Degeorge, Bat B 2ieme etage
- City
- ARRAS Pas-de-Calais
- Country
- FR
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
US Agent
- Business Name
- Beckman Coulter, Inc.
- Contact Name
- Ian Pilcher
- Address
- 1000 Lake Hazeltine Dr
- City
- Chaska
- State
- MN
- ZIP
- 55318
- Country
- US
- [email protected]
- Phone
- 443 3506459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2000-10-04 |
Proprietary Names
AutoMate 2500 Sample Processing System
AutoMate 1200 Sample Processing System
AutoMate 2550 Sample Processing System
AutoMate 1250 Sample Processing System
ODL25250 AutoMate 2500 LAB INSTRUMENT
ODL25255 AutoMate 2550 LAB INSTRUMENT
A18894 Automate 800 Sample Processing System
ODL25120 AutoMate 1200 LAB INSTRUMENT
A18896 Automate 600 Sample Processing System
ODL25125 AutoMate 1250 LAB INSTRUMENT
Command Central
Kaluza C Perpetual License (PN C10574)
Kaluza C Flow Cytometry Software (PN C21166)
Kaluza C Single Use 1 Year License (PN C10575)
Kaluza C 10 User Network (PN C10576)
DxOne Workflow Manager
Kaluza C 5 User Network (PN C10577)
REMISOL ADVANCE
Establishment Types
Manufacture Medical Device