FDA Registration
Active
🇩🇪 Germany
Lysercell WPC
Reg #: 3005626422
·
FEI: 3005626422
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sysmex Europe SE
- Registration Number
- 3005626422
- FEI Number
- 3005626422
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Mainstrasse 7
- City
- Neumunster Schleswig-Holstein
- Country
- DE
Owner / Operator
- Firm Name
- SYSMEX CORPORATION
- Operator Number
- 9014170
- Address
- 4-4-4 TAKATSUKADAI, NISHI-KU
- City
- KOBE
- State
- JP-NOTA
- Postal Code
- 651-2271
- Country
- JP
US Agent
- Business Name
- SYSMEX AMERICA, INC
- Contact Name
- Simon C. Shorter
- Address
- 577 APTAKISIC RD
- City
- Lincolnshire
- State
- IL
- ZIP
- 60069
- Country
- US
- [email protected]
- Phone
- 408 8380220
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2007-05-07 |
Proprietary Names
Lysercell WPC
Lysercell WDF
Lysercell WNR
Sulfolyser
XW pack L
Stromatolyser-4DS
Stromatolyser-WH
Stromatolyser-4DL
Stromatolyser-3WP
Stromatolyser-NR
Stromatolyser-IM
Stromatolyser-FB
Stromatolyser-NR(L)
pocH-pack L
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)