FDA Registration
Active
🇮🇪 Ireland
BT12 ECG
Reg #: 3002808458
·
FEI: 3002808458
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- VITALOGRAPH IRELAND LTD.
- Registration Number
- 3002808458
- FEI Number
- 3002808458
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gort Road Business Park, Ennis
- City
- Co Clare
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K082077
Owner / Operator
- Firm Name
- Vitalograph Ireland Ltd.
- Operator Number
- 10024235
- Address
- Gort Road Business Park, Ennis
- City
- Co Clare
- State
- IE-CE
- Postal Code
- V95 HFT4
- Country
- IE
US Agent
- Business Name
- Vitalograph Inc
- Contact Name
- Chris McKinney
- Address
- 13310 W. 99th St.
- City
- Lenexa
- State
- KS
- ZIP
- 66215
- Country
- US
- [email protected]
- Phone
- 913 7303207
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2018-03-09 |
Proprietary Names
BT12 ECG
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device