FDA Registration
Active
🇨🇦 Canada
Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)
Reg #: 9681860
·
FEI: 3003491392
·
Expires 2026
Products
18
Proprietary Names
0
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)
- Registration Number
- 9681860
- FEI Number
- 3003491392
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 215 Herbert St.
- City
- GANANOQUE Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K955882
- PMA Number
- P190007
Owner / Operator
- Firm Name
- Cardinal Health 200, LLC
- Operator Number
- 9028292
- Address
- 3651 Birchwood Drive, --
- City
- Waukegan
- State
- IL
- Postal Code
- 60085
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2006-05-12 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2019-05-09 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2019-05-09 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2009-09-03 |
| Board, Arm (With Cover), Sterile | BTX | Class 1 | General, Plastic Surgery | No | 2004-03-22 |
| Monitor, Pressure, Intrauterine | KXO | Class 2 | Obstetrics/Gynecology | No | 2006-09-22 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2008-01-11 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2006-05-26 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2001-07-27 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1996-12-16 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2014-12-04 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2007-04-26 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2012-04-04 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2008-01-11 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1995-08-03 |
| Board, Arm (With Cover), Non-Sterile | NOD | Class 1 | General, Plastic Surgery | No | 2024-05-29 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2013-12-13 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device