FDA Registration
Active
🇨🇭 Switzerland
HAMILTON BONADUZ AG
Reg #: 8030996
·
FEI: 3001421318
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HAMILTON BONADUZ AG
- Registration Number
- 8030996
- FEI Number
- 3001421318
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA CRUSCH 8
- City
- BONADUZ Graubunden
- Country
- CH
Regulatory Submissions
- 510(k) Number
- BK130006
Owner / Operator
- Firm Name
- HAMILTON BONADUZ AG
- Operator Number
- 8030996
- Address
- VIA CRUSCH 8, --
- City
- BONADUZ
- State
- CH-NOTA
- Postal Code
- 7402
- Country
- CH
US Agent
- Business Name
- Director of Quality Assurance
- Contact Name
- Tim Zavora
- Address
- 4970 Energy Way
- City
- Reno
- State
- NV
- ZIP
- 89502
- Country
- US
- [email protected]
- Phone
- 775 4516566
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2014-11-26 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | JJC | Class 1 | Clinical Chemistry | No | 2013-02-05 |
| Test, Equipment, Automated Bloodborne Pathogen | MZA | Class N | Unknown | No | 2020-11-26 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2016-06-07 |
Proprietary Names
cobas prime Tip rack tray
cobas prime Universal Tray
cobas prime Secondary Tube
AltoStar Automation System AM16
Microlab STAR, Microlab STARlet
ELITE
BK130006
VERSANT Molecular System SP Module, Stand Alone Sample Prep SASP
Establishment Types
Manufacture Medical Device