FDA Registration
Active
🇨🇭 Switzerland
TECAN SCHWEIZ AG
Reg #: 3003402518
·
FEI: 3003402518
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TECAN SCHWEIZ AG
- Registration Number
- 3003402518
- FEI Number
- 3003402518
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 103 SEESTRASSE
- City
- MAENNEDORF ZUERICH Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- BK210564
Owner / Operator
- Firm Name
- Tecan Group AG
- Operator Number
- 9050992
- Address
- 103 Seestrasse, --
- City
- Maennedorf
- State
- Zurich
- Postal Code
- 8708
- Country
- CH
US Agent
- Business Name
- Tecan U.S.
- Contact Name
- Taunya Alexander
- Address
- 9401 Globe Center Dr Ste 140
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 919 5725421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Automated Blood Grouping And Antibody | KSZ | Class 2 | Hematology | No | 2021-07-03 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)