FDA Registration
Active
🇨🇭 Switzerland
STRATEC Switzerland AG
Reg #: 3008494306
·
FEI: 3008494306
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRATEC Switzerland AG
- Registration Number
- 3008494306
- FEI Number
- 3008494306
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Neuwiesenstrasse 4
- City
- Beringen Schaffhausen
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K223403
Owner / Operator
- Firm Name
- STRATEC Switzerland AG c/o STRATEC SE
- Operator Number
- 9090484
- Address
- Gewerbestrasse 37
- City
- Birkenfeld
- 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, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2024-07-18 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)