FDA Registration
Active
🇺🇸 United States
Air-Charged Catheters
Reg #: 3017448360
·
FEI: 3017448360
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- LABORIE MEDICAL TECHNOLOGIES CORP.
- Registration Number
- 3017448360
- FEI Number
- 3017448360
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 180 International Drive
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
Owner / Operator
- Firm Name
- Laborie Medical Technologies Corp.
- Operator Number
- 10079684
- Address
- 180 International Drive
- City
- Portsmouth
- State
- NH
- Postal Code
- 03801
- Country
- US
- Correspondent
- Nicole Boser
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2021-07-29 |
Proprietary Names
Air-Charged Catheters
Electrodes
T-DOC Air-Charged Dual Sensor Catheter
T-DOC Air-Charged Single Sensor Catheter
Abdominal Pressure Catheter
T-DOC Air-Charged Abdominal Sensor Catheter
T-DOC Air-Charged Catheter
Pump Tubing Infusion Line
Coude Dual Lumen Catheter
Infusion Pump Tube Set
Air-Charged Reusable Cable
Cystometry Pack
Bladder Pressure Catheter
Urodynamic Measurement Tubing
Urodynamic Catheters
Solar Blue, Nexam
eSense® Urodynamic Catheters
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198