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Medical Device Division · registration 140164Active

Cook

Hong KongNeedles, Catheter IntroductionClass IICook Incorporated
Official record identity
MDACS listing number
140164
Model name
Check-Flo Performer Introducer (RCFW-5.0-35, RCFW-10.0-38, RCFW-10.0-38-30-RB, RCFW-10.0-38-45-RB, RCFW-10.0-38-60-RB,RCFW-10.0-38-80-RB, RCFW-11.0-38-30-RB, RCFW-11.0-38-70-RB, RCFW-12.0-38,RCFW-12.0-38-30-RB, RCFW-12.0-38-45-RB, RCFW-12.0-38-65-RB, RCFW-12.0-38-80-RB, RCFW-12.0-38-RB, RCFW-14.0-38-30-RB, RCFW-14.0-38-45-RB, RCFW-14.0-38-80-RB, RCFW-16.0P-38-30-RB, RCFW-16.0P-38-35-RB, RCFW-16.0P-38-45-RB, RCFW-16.0P-38-70-RB, RCFW-16.0P-38-80-RB, RCFW-16.0P-38-RB, RCFW-18.0P-38-30-RB, RCFW-18.0P-38-40-RB, RCFW-18.0P-38-85-RB, RCFW-6.0-35-RB, RCFW-6.0-38-30-RB, RCFW-7.0-38-30-RB, RCFW-7.0-38-80-RB, RCFW-8.0-38-30-RB,RCFW-9.0-38-30-RB)
Registration date
June 18, 2024
Expiry date
June 17, 2029
Source update date
May 02, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Needles, Catheter Introduction
Published parties
Registrant / registration holder
Cook Asia Ltd
Official description

Needles, Catheter Introduction

Additional source fields
AMD nomenclature code
20244
Local responsible person phone
34721688
Published manufacturer address
750 Daniels Way, Bloomington IN 47404, USA
Revision number
c
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.