Medical Device Division · registration 160275Active

Coloplast

Name: Coloplast — Medical Device Division 160275
Creator: Coloplast A/S
Keywords: Coloplast, Coloplast, 160275, Procedure Kit/Trays, Implant Delivery, Stent, Ureter, Medical Device Division

Hong KongProcedure Kit/Trays, Implant Delivery, Stent, UreterClass IIIColoplast A/S

Verified

Official record identity

MDACS listing number: 160275
Model name: Biosoft Duo Double Loop Ureteral Stent Kit (BCAA62, BCAA63, BCAA64, BCAA65, BCAA66, BCAA67, BCAA72, BCAA73, BCAA74, BCAA75, BCAA76, BCAA77, BCAA84, BCAA85, BCAA86, BCAA94, BCAA95, BCAA96, BCAJ62, BCAJ63, BCAJ64, BCAJ65, BCAJ66, BCAJ67, BCAJ72, BCAJ73, BCAJ74, BCAJ75, BCAJ76, BCAJ77, BCAJ84, BCAJ85, BCAJ86, BCAJ94, BCAJ95, BCAJ96, BNAB63, BNAB64, BNAB65, BNAB74, BNAB75), Biosoft Duo Multilength Hydro-Coated Double Loop Ureteral Stent Kit (BCGA58, BCGA68, BCGA78)
Registration date: January 23, 2026
Expiry date: August 22, 2031
Source update date: January 29, 2026
Status: Active

Classification

Risk class: Class III
Published category: Procedure Kit/Trays, Implant Delivery, Stent, Ureter

Published parties

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

Official description

Procedure Kit/Trays, Implant Delivery, Stent, Ureter

Additional source fields

AMD nomenclature code: 17693
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: e

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.