This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


  1. Home
  2. Registered Medical Device Search
  1. Print

DEVICE DETAILS

NAME OF DEVICEFLEXOR CHECK-FLO INTRODUCER
ESTABLISHMENT NAMECOOK ASIA (MALAYSIA) SDN BHD
REGISTRATION NOGB5300419-34174
BRAND NAMECOOK
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONFLEXOR CHECK-FLO INTRODUCERS ARE DESIGNED TO PERFORM AS A GUIDING SHEATH AND/OR INTRODUCER SHEATH, AND CAN BE ORDERED WITH VARIOUS PROXIMAL FITTINGS SUCH AS A TUOHY-BORST VALVE OR A CHECK-FLO® VALVE. SOME INTRODUCER SETS ARE AVAILABLE WITH A RADIOPAQUE BAND INCORPORATED WITHIN THE SHEATH MATERIAL TO IDENTIFY THE LOCATION OF THE SHEATH%U2019S DISTAL TIP, WHILE OTHER SETS ARE AVAILABLE WITH AQ® HYDROPHILIC COATING TO PROVIDE A LUBRICIOUS SURFACE TO EASE INSERTION.
DEVICE INTENDED PURPOSEFLEXOR CHECK-FLO INTRODUCERS ARE INTENDED FOR INTRODUCTION OF BALLOONS, CLOSED AND NON-TAPERED END CATHETERS OR OTHER DIAGNOSTIC AND INTERVENTIONAL DEVICES.
VALIDITY DATE OF REGISTRATION29/08/2019 - 28/08/2024

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Flexor Check-Flo Introducer Raabe ModificationKCFW-4.0-35-55-RB-RAABE
2Flexor Check-Flo Introducer Raabe ModificationKCFW-5.0-38-55-RB-RAABE
3Flexor Check-Flo Introducer Raabe ModificationKCFW-6.0-38-55-RB-RAABE
4Flexor Check-Flo Introducer Raabe ModificationKCFW-6.0-38-90-RB-RAABE
5Flexor Check-Flo Introducer Raabe ModificationKCFW-7.0-38-55-RB-RAABE
6Flexor Check-Flo Introducer Raabe ModificationKCFW-7.0-38-70-RB-RAABE
7Flexor Check-Flo Introducer Raabe ModificationKCFW-7.0-38-90-RB-RAABE
8Flexor Check-Flo Introducer Ansel ModificationKCFW-4.0-18/35-45-RB-ANL0-HC
9Flexor Check-Flo Introducer Ansel ModificationKCFW-4.0-18/35-90-RB-ANL0-HC
10Flexor Check-Flo Introducer Ansel ModificationKCFW-5.0-18/38-45-RB-ANL0-HC
11Flexor Check-Flo Introducer Ansel ModificationKCFW-6.0-18/38-45-RB-ANL0-HC
12Flexor Check-Flo Introducer Ansel ModificationKCFW-7.0-18/38-45-RB-ANL0-HC
13Flexor Check-Flo Introducer Ansel ModificationKCFW-8.0-18/38-45-RB-ANL0-HC
14Flexor Check-Flo Introducer Ansel ModificationKCFW-9.0-18/38-45-RB-ANL0-HC
15Flexor Check-Flo Introducer Ansel ModificationKCFW-5.0-18/38-45-RB-ANL1-HC
16Flexor Check-Flo Introducer Ansel ModificationKCFW-5.0-18/38-90-RB-ANL1-HC
17Flexor Check-Flo Introducer Ansel ModificationKCFW-6.0-18/38-45-RB-ANL1-HC
18Flexor Check-Flo Introducer Ansel ModificationKCFW-7.0-18/38-45-RB-ANL1-HC
19Flexor Check-Flo Introducer Ansel ModificationKCFW-8.0-18/38-45-RB-ANL1-HC
20Flexor Check-Flo Introducer Ansel ModificationKCFW-9.0-18/38-45-RB-ANL1-HC
21Flexor Check-Flo Introducer Ansel ModificationKCFW-5.0-18/38-45-RB-ANL2-HC
22Flexor Check-Flo Introducer Ansel ModificationKCFW-6.0-18/38-45-RB-ANL2-HC
23Flexor Check-Flo Introducer Ansel ModificationKCFW-7.0-18/38-45-RB-ANL2-HC
24Flexor Check-Flo Introducer Ansel ModificationKCFW-6.0-18/38-45-RB-ANL3-HC
25Flexor Check-Flo Introducer Balkin Up & Over Contralateral DesignKCFW-6.0-38-40-RB-BLKN
26Flexor Check-Flo Introducer Balkin Up & Over Contralateral DesignKCFW-7.0-38-40-RB-BLKN
27Flexor Check-Flo Introducer Balkin Up & Over Contralateral DesignKCFW-8.0-38-40-RB-BLKN
Back