FDA Registration
Active
🇨🇦 Canada
CANADIAN HOSPITAL SPECIALTIES LTD
Reg #: 3003627840
·
FEI: 3003627840
·
Expires 2026
Products
17
Proprietary Names
18
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- CANADIAN HOSPITAL SPECIALTIES LTD
- Registration Number
- 3003627840
- FEI Number
- 3003627840
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1213 International Blvd.
- City
- Burlington Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K131183
Owner / Operator
- Firm Name
- Canadian Hospital Specialties Ltd.
- Operator Number
- 10044194
- Address
- 2060 Winston Park Dr., Suite 400
- City
- Oakville
- State
- Ontario
- Postal Code
- L6H 5R7
- Country
- CA
- Correspondent
- Cheryl Brown
US Agent
- Business Name
- P/L Biomedical
- Contact Name
- Lee Leichter
- Address
- 20004 Nickel Trl
- City
- Alva
- State
- FL
- ZIP
- 33920
- Country
- US
- [email protected]
- Phone
- 239 9946488
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2017-11-14 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2017-01-29 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2019-10-31 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2017-03-02 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2015-01-16 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2021-03-04 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-09-29 |
| Protector, Hearing (Circumaural) | EWE | Class U | Unknown | No | 2025-07-17 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2021-03-04 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-02-28 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2017-02-28 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2017-02-28 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2017-02-28 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2017-11-27 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2022-06-17 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2017-01-29 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2017-11-14 |
Proprietary Names
MED-RX ORAL/ENTERAL SYRINGE
MED-RX PATIENT DELIVERY SET
MED-RX
MED-RX EXTENSION SETS
MED-RX Insufflation Filter Set
Disposable CT/MR Syringes for Nemoto Injectors
Asept, Safely Drain Line Adapter
MED-RX Transfer Set
Pre-Vac Sterile Wound Drainaige Bottle 1000 ml w/tubing
Pre-Vac Drainaige Bottle 1000 ml tubing non sterile
Spike tubing
Mini Muffs
PRE-VAC CLOSED WOUND DRAINAGE SYSTEM; PAHSCO-VAC CLOSED WOUND DRAINAGE SYSTEM; PRE-VAC WOUND DRAINAGE BOTTLE
MED-RX Suction Catheter
MED-RX Cysto/Bladder Irrigation Set
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
MED-RX Oral Syringe
MED-RX EXTENSION SET WITH T-CONNECTOR
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility