FDA Registration
Active
🇬🇧 United Kingdom
Microdot Test Strips
Reg #: 3004176168
·
FEI: 3004176168
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CAMBRIDGE SENSORS LIMITED
- Registration Number
- 3004176168
- FEI Number
- 3004176168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- UNITS 9&10 CARDINAL PARK, GODMANCHESTER
- City
- HUNTINGDON, Cambridgeshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K070524
Owner / Operator
- Firm Name
- CAMBRIDGE SENSORS LIMITED
- Operator Number
- 9057881
- Address
- UNITS 9&10 CARDINAL PARK, GODMANCHESTER
- City
- HUNTINGDON
- State
- Cambridgeshire
- Postal Code
- PE29 2XG
- Country
- GB
US Agent
- Business Name
- CAMBRIDGE SENSORS USA, LLC
- Contact Name
- FRED ENGIMANN
- Address
- 23866 W INDUSTRIAL DR N
- City
- Plainfield
- State
- IL
- ZIP
- 60585
- Country
- US
- [email protected]
- Phone
- 630 4284240
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2008-02-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2008-02-14 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2008-02-14 |
Proprietary Names
Microdot Test Strips
Establishment Types
Manufacture Medical Device