FDA Registration
Active
🇩🇪 Germany
?-Hydroxybutyrate 21 FS
Reg #: 3006644620
·
FEI: 3006644620
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DIASYS DIAGNOSTIC SYSTEMS GMBH
- Registration Number
- 3006644620
- FEI Number
- 3006644620
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ALTE STRASSE 9
- City
- Holzheim Rhineland-Palatinate
- Country
- DE
Owner / Operator
- Firm Name
- DIASYS DIAGNOSTIC SYSTEMS GMBH
- Operator Number
- 9105042
- Address
- ALTE STRASSE 9, --
- City
- HOLZHEIM, RHEINLAND-PFALZ
- State
- DE-NOTA
- Postal Code
- D-65558
- Country
- DE
US Agent
- Business Name
- DiaSys Diagnostic Systems, USA, LLC
- Contact Name
- Markus Rick
- Address
- 28287 Beck Road, Building D-15
- City
- Wixom
- State
- MI
- ZIP
- 48393
- Country
- US
- [email protected]
- Phone
- 800 4669106
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2018-09-17 |
Proprietary Names
?-Hydroxybutyrate 21 FS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device