FDA Registration
Active
🇨🇦 Canada
NUMED CANADA, INC.
Reg #: 9618000
·
FEI: 3003245778
·
Expires 2026
Products
7
Proprietary Names
23
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- NUMED CANADA, INC.
- Registration Number
- 9618000
- FEI Number
- 3003245778
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 45 Second Street West
- City
- CORNWALL Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K102473
Owner / Operator
- Firm Name
- NUMED CANADA, INC.
- Operator Number
- 9044991
- Address
- 45 SECOND ST., --
- City
- CORNWALL, ONTARIO
- State
- CA-NOTA
- Postal Code
- K6J 1G3
- Country
- CA
US Agent
- Business Name
- NUMED, INC.
- Contact Name
- NICHELLE LAFLESH
- Address
- 2880 MAIN ST.
- City
- HOPKINTON
- State
- NY
- ZIP
- 12965
- Country
- US
- [email protected]
- Phone
- 315 3284491
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | Class 2 | Cardiovascular | No | 2016-04-19 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2007-10-19 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2016-06-10 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2007-10-19 |
| Balloon Aortic Valvuloplasty | OZT | Class 2 | Cardiovascular | No | 2012-10-16 |
| Catheter, Septostomy | DXF | Class 2 | Cardiovascular | No | 2021-10-15 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2007-10-19 |
Proprietary Names
Mullins-X
Tyshak II
Z-MED II
Tyshak NuCLEUS
COEfficient
PTS
PTS-X
Tyshak Mini
NuCLEUS-X
NuCLEUS
Z-MED
Ghost
Tyshak
Z-MED and Z-MED II
Z-6 Atrioseptostomy Catheter
Mini Ghost
Tyshak-X
Z-MED II-X
Z-MED-X
Ghost II
Tyshak PTV
Z-MED PTV
Z-5 Atrioseptostomy
Establishment Types
Manufacture Medical Device