FDA Registration
Active
🇨🇭 Switzerland
TECAN SCHWEIZ AG
Reg #: 3003402518
·
FEI: 3003402518
·
Expires 2026
Products
11
Proprietary Names
15
Establishment Types
3
Classifications
11
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Registration Details
- Registration Name
- TECAN SCHWEIZ AG
- Registration Number
- 3003402518
- FEI Number
- 3003402518
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 103 SEESTRASSE
- City
- MAENNEDORF ZUERICH Zurich
- Country
- CH
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 |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2005-02-22 |
| Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma | QBZ | Class 1 | Clinical Chemistry | No | 2019-11-15 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2012-04-25 |
| Blood Establishment Computer Software And Accessories | MMH | Class 2 | Hematology | No | 2018-03-12 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2016-03-08 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2008-01-17 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2012-12-12 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2005-02-23 |
| System, Test, Automated Blood Grouping And Antibody | KSZ | Class 2 | Hematology | No | 2021-07-02 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2001-11-06 |
| Research Use Only/Clinical Chemistry Devices | OTV | Class N | Unknown | No | 2017-12-15 |
Proprietary Names
Freedom EVOlyzer
PROFI BLOT 48-2in1
PROFI BLOT T48
PROFI BLOT 48
Freedom EVO 75 :
Freedom EVO :
Freedom EVOlyzer :
Genesis FE 500 :
Freedom EVO Clinical :
Fluent
AVENIO Edge System
AcfS Detection Robot
AcfS Library Robot
Veya Dx
AcfS L&D Equipment Installation Bundle
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility