FDA Registration
Active
🇩🇪 Germany
GEMINI Compact Microplate Processor
Reg #: 8043379
·
FEI: 3003413192
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STRATEC SE
- Registration Number
- 8043379
- FEI Number
- 3003413192
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- GEWERBESTRASSE 37
- City
- BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- STRATEC SE
- Operator Number
- 9001219
- Address
- GEWERBESTRASSE 37, --
- City
- BIRKENFELD, GRAEFENHAUSEN, BW
- State
- Baden-Wurttemberg
- Postal Code
- 75217
- Country
- DE
- Correspondent
- VOLKER - SCHWAAB
US Agent
- Business Name
- Diatron US Inc.
- Contact Name
- Frank Matuszak
- Address
- 12601 NW 115th Avenue Suite A 113
- City
- Medley
- State
- FL
- ZIP
- 33178
- Country
- US
- [email protected]
- Phone
- 833 2287931
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2008-06-10 |
Proprietary Names
GEMINI Compact Microplate Processor
GEMINI Combo
KleeYa instrument
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device