FDA Registration
Active
🇬🇧 United Kingdom
V8 Nexus Electrophoresis Instrument
Reg #: 3009736003
·
FEI: 3009736003
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Helena Laboratories UK Ltd
- Registration Number
- 3009736003
- FEI Number
- 3009736003
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Queensway South, Team Valley Trading Estate
- City
- Gateshead Newcastle upon Tyne
- Country
- GB
Owner / Operator
- Firm Name
- Helena Biosciences Europe
- Operator Number
- 10041365
- Address
- Queensway South, Team Valley Trading Estate
- City
- Gateshead
- State
- GB-GAT
- Postal Code
- NE11 0SD
- Country
- GB
- Correspondent
- Carol J Sandercock
US Agent
- Business Name
- Director of Regulatory Affairs
- Contact Name
- Rachel Easley
- Address
- 1530 Lindbergh Drive, Beaumont
- City
- Beaumont
- State
- TX
- ZIP
- 77707
- Country
- US
- [email protected]
- Phone
- 409 8423714 ext. 1275
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrophoretic, Protein Fractionation | CEF | Class 1 | Clinical Chemistry | No | 2012-07-27 |
Proprietary Names
V8 Nexus Electrophoresis Instrument
V8 UltraCE Electrophoresis Instrument
Establishment Types
Manufacture Medical Device