FDA Registration
Active
🇲🇾 Malaysia
BARD SDN. BHD.
Reg #: 8040607
·
FEI: 3002806591
·
Expires 2026
Products
9
Proprietary Names
107
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- BARD SDN. BHD.
- Registration Number
- 8040607
- FEI Number
- 3002806591
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 57-C, KULIM INDUSTRIAL ESTATE
- City
- KULIM Kedah
- Country
- MY
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2007-12-12 |
| Catheter, Urological (Antimicrobial) And Accessories | MJC | Class 2 | Gastroenterology, Urology | No | 2007-12-07 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2018-01-25 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2007-03-14 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2007-02-27 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2018-01-10 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2007-03-14 |
| Catheter, Malecot | FEW | Class 2 | Gastroenterology, Urology | No | 2007-12-10 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2007-12-11 |
Proprietary Names
Bard Red Rubber Utility Catheter
SureStep Intermittent Catheter Tray
Hydrogel/Silver-Coated Foley Cath
& Foley Tray (I.C.)
Bardex I.C. Foley Catheter (offered in strips and trays)
PTFE Coated Foley Catheter w/ urine collection bag
LubriSil Foley Catheter w/ collection bag
PTFE Coated Foley Catheter w/ Leg Bag
Hydrogel Coated Foley Catheter with Leg Bag
Silicone Catheter Tray with Accessories including Leg Bag
Hydrogel Coated Foley Catheter with Urine Collection Bag
LubriSil Foley Catheter with Leg Bag
Bard Foley Tray with Bardex All Silicone Foley Catheter (for Canada)
PTFE Coated Foley Catheter w/ Urine Meter
SureStep Foley Tray System Bardex All- Silicone Foley Catheter Tray (for Canada)
Silicone Catheter Tray with accessories
LubriSil Foley Catheter with urine collection bag
Silicone Foley Catheter w/ urine collection bag
PTFE Coated Foley Catheter w/ Bed Bag
Hydrogel Coated Foley Catheter w/ urine collection container
LubriSil Foley Catheter w/ urine collection container
PTFE Coated Foley Catheter w/ urine collection container
SureStep Foley Tray System Lubri-Sil Complete Care (for Canada)
Bard Urine Meter Foley Tray With Bardex All-Silicone Foley Catheter (for Canada)
SureStep Foley Tray System Bard Lubri-Sil Foley Catheter Tray (for Canada)
SureStep Foley Tray System Bard All Silicone Foley Catheter Tray (for Canada)
Coude Tip Temperature-Sensing Cath
CritiCore (Coude) Foley Tray
Loc-Strap
Bard Male External Catheter (OTC)
Bard Infection Control Urinary
Needleless Sample Port Control Fit
Urine Collection Container -
bag/urinary drainage unit
Bard Deluxe Dispoz-A-Bag Drainage
Bag (Leg Bag)
Urinary Drainage Unit(urinary leg
Urotrack Plus (Model 220)
Bard Leg Bag Holder
w/ accessories)
Bed Bag
SureStep Foley Tray System Add-A-Foley Catheter (for Canada)
Bard Foley Catheterization Tray Uro-Prep Tray (for Canada)
SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada)
Bard Standard Latex Free Foley Tray without Catheter (for Canada)
Bard Male External Latex Disposable Catheter
Bardia Foley Catheter Insertion
w/o Catheter with Lubricant in
Bard® Universal Catheterization Tray
Bardia Urethral Catheter Tray
5cc Balloon w/o Catheter
w/o Catheter
Foley Catheter Insertion Tray for
30cc Balloon w/o Catheter
Bard Foley Catheterization Tray
All-Silicone Foley Catheter
Lubri-Sil Foley Catheter (offered in strips and trays)
Lubri-Sil I.C. Foley Catheter (offered in strips and trays)
Bardex Silicone Foley Catheter (offered in strips and trays)
Rubber Utility Catheter
Vacuum Tubing
Patient Tubing
PureWick FEC
Collection Canister
PureWick Urine Collection Accessories Kit
PureWick Urine Collection System
PureWick MEC
PureWick Male External Catheter
PureWick Female External Catheter
Bardex I.C. Pediatric Foley Cath
I.C. Foley Catheter with Urine Collection Container
I.C. Foley Catheter AquaFil
Foley Catheter with Syringe
Foley Catheter with AquaFil
Magic3 Touchless Hydrophilic Intermittent Catheter System (for Canada)
SureStep Foley Tray System Bardex IC Complete Care (for Canada)
Lubri-Sil I.C. Complete Care Urine Meter Foley Tray (for Canada)
SureStep Foley Tray System Bardex I.C. Complete Care Foley Catheter (for Canada)
SureStep Foley Tray System Lubri-Sil IC Complete Care (for Canada)
Touchless II Pre-Lubricated
Urethral Kit
Bardex Pezzers
Bardex Nephrostomy
Bardex Angel Drain
Bardex Malecot
Latex Foley Catheter with 30cc
Preformed Balloon
Bardia Foley Catheter
Bard Lubricath Foley Catheter
Hydrogel-Coated Foley Catheter
Funnel
Stomach/Intestinal Tube with Bulb
Latex Foley Catheter & Drains
Bardex Councill Model Foley Catheter Percutaneous Nephrostomy
Bardex Nephrostomy Short Tip Councill Model Foley Catheter with Heyman Stylet
Lubricath Foley Catheter (offered in strips and trays)
Bard Urologist Tray
Bard Urologist Tray (for Canada)
Hydrogel-Coated Urethral Catheter
Silastic Brand Foley Catheter
Bard® Silastic® Foley Catheter
Bardex I.C. 4-Way Foley Catheter
Latex Foley Catheter
Bard Urethral Catheterization Tray
Bard Latex Urethral Catheter
(Tieman Model) Coude Tip
Bardia Red Rubber Intermittent Catheters
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)