FDA Registration
Active
🇮🇪 Ireland
MEDISIZE IRELAND LTD.
Reg #: 8020864
·
FEI: 3005737257
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MEDISIZE IRELAND LTD.
- Registration Number
- 8020864
- FEI Number
- 3005737257
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HIGH ROAD
- City
- LETTERKENNY Donegal
- Country
- IE
Owner / Operator
- Firm Name
- Phillips-Medisize, LLC
- Operator Number
- 2183833
- Address
- 2202 Carmichael Rd
- City
- Hudson
- State
- WI
- Postal Code
- 54016
- Country
- US
US Agent
- Business Name
- Phillps-Medisize, LLC
- Contact Name
- Julie Weghorn
- Address
- 408 Red Cedar Street, Suite 6
- City
- Menomonie
- State
- WI
- ZIP
- 54751
- Country
- US
- [email protected]
- Phone
- 715 8315443
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nitric Oxide Generator And Delivery System | QTB | Class 3 | Unknown | No | 2022-11-17 |
| Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus | QVN | Class 2 | Ear, Nose, Throat | No | 2023-03-08 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2014-11-13 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2017-12-18 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2025-09-24 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2025-09-24 |
Proprietary Names
LungFit PH NO2 Filter
Lenire
TECA MYOJECT - LUER LOCK - DISPOSABLE NEEDLE ELECTRODE
CT ExpresTM 3D Contrast Media Delivery System
Luer Elbow 7.6mm Port Kit (90016)
10mm Gas Sample Adaptor Kit (90006)
22mm Gas Sample Adaptor Kit (90017)
15mm Gas Sample Adaptor Kit (90007)
TECA Myoject - Luer lock - Disposable hypodermic needle electrode
Bo-ject® DHN Disposable Hypodermic Needle Electrode
Sample Line Kit (90031)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)