FDA Registration
Active
🇦🇹 Austria
HYDROFLEX EVOLYZER 8CH
Reg #: 3002710220
·
FEI: 3002710220
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- TECAN AUSTRIA GMBH
- Registration Number
- 3002710220
- FEI Number
- 3002710220
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1A UNTERSBERGSTRASSE
- City
- GROEDIG Salzburg
- Country
- AT
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 |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2005-02-23 |
Proprietary Names
HYDROFLEX EVOLYZER 8CH
COLUMBUS
HYDROFLEX
HYDROFLEX PLUS
HYDROFLEX ELISA
HYDROSPEED
HYDROFLEX FREEDOM EVO
96PW
PW384
HYDROFLEX EVOLYZER 16CH
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device