FDA Registration
Active
🇦🇹 Austria
SUNRISE BF
Reg #: 3002710220
·
FEI: 3002710220
·
Expires 2025
Products
1
Proprietary Names
28
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 |
|---|---|---|---|---|---|
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2007-12-21 |
Proprietary Names
SUNRISE BF
SUNRISE-RC/ST TC CRE
SUNRISE BF V2
SUNRISE-RC/ST EVOLYZER
INFINITE 200 PRO - INFINITE F Plex
INFINITE 200 PRO - INFINITE F Nano+
INFINITE 200 PRO - INFINITE M Plex
INFINITE 200 PRO - INFINITE M Nano+
INFINITE 200 PRO - INFINITE Lumi
INFINITE 200 PRO - INFINITE M Nano
INFINITE F50 PLUS
INFINITE F50
INFINITE F500
INFINITE 200
SUNRISE-RC/6F EVOLYZER
INFINITE M1000
INFINITE F50 ROBOTIC
INFINITE M1000 PRO
SUNRISE
SUNRISE-RC/ST GL.ABBOTT
INFINITE F50 ROBOTIC FS
SUNRISE-RC/ST RMP
SUNRISE-RC/6F ENFER
SUNRISE-RC/ST ML
SUNRISE-RC/TW EVOLYZER
INFINITE 200 PRO
SUNRISE-RC/ST GENALYSER
PR4100
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)