FDA Registration
Active
🇮🇪 Ireland
CHOLRIDE ELECTRODE (I.S.E. Cl)
Reg #: 3009473156
·
FEI: 3009473156
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Randox Teoranta
- Registration Number
- 3009473156
- FEI Number
- 3009473156
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Meenmore
- City
- Dungloe Donegal
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K230890
Owner / Operator
- Firm Name
- RANDOX LABORATORIES, LTD.
- Operator Number
- 8020890
- Address
- 55 DIAMOND RD., --
- City
- CRUMLIN, CO.ANTRIM
- State
- GB-NOTA
- Postal Code
- BT29 4QY
- Country
- GB
- Correspondent
- Karena - Shaw
US Agent
- Business Name
- RANDOX LABORATORIES-US, LTD
- Contact Name
- Sammy Alnajm
- Address
- 515 Industrial Boulevard
- City
- Kearneysville
- State
- WV
- ZIP
- 25430
- Country
- US
- [email protected]
- Phone
- 304 7282890
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2023-09-20 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2023-09-20 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2023-09-20 |
Proprietary Names
CHOLRIDE ELECTRODE (I.S.E. Cl)
POTASSIUM ELECTRODE (I.S.E. K)
SODIUM ELECTRODE (I.S.E. Na)
Establishment Types
Foreign Private Label Distributor