Medical Device Division · registration 160489Active

Coloplast

Name: Coloplast — Medical Device Division 160489
Creator: Coloplast A/S
Keywords: Coloplast, Coloplast, 160489, Catheters, Urinary, Nephrostomy, Medical Device Division

Hong KongCatheters, Urinary, NephrostomyClass IIIColoplast A/S

Verified

Official record identity

MDACS listing number: 160489
Model name: Malecot Percutaneous Nephrostomy Catheter (RCM008, RCM010, RCM012, RCM014, RCM016, RCM018, RCM020)
Registration date: July 29, 2026
Expiry date: January 05, 2032
Source update date: July 30, 2026
Status: Active

Classification

Risk class: Class III
Published category: Catheters, Urinary, Nephrostomy

Published parties

Registrant / registration holder: Keymax Technology (Hong Kong) Ltd.
Manufacturer: Coloplast A/S

Official description

Catheters, Urinary, Nephrostomy

Additional source fields

AMD nomenclature code: 10735
Traditional Chinese local responsible person: 啟盈科技 (香港) 有限公司
Local responsible person phone: 31508289
Published manufacturer address: Holtedam 1, 3050 Humlebaek, Denmark
Revision number: d

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.