Prostheses, Penile, Inflatable假体,, 充气

This profile provides complete Hong Kong MDACS registration information for Prostheses, Penile, Inflatable. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Prostheses, Penile, Inflatable

產品資訊： 假体,, 充气

Device Overview

Hong Kong MDACS registration summary and classification details.

Risk Class

III

Product Code

17997

Product Code Detail

17997 Prostheses, Penile, Inflatable

State

current

Status

N/A

DJ Fang

MedTech Regulatory Expert

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Pricing

Manufacturer (製造商)

Coloplast A/S

Coloplast

Denmark

丹麦

Holtedam 1, 3050 Humlebaek, Denmark

Holtedam 1, 3050 胡姆勒拜克, 丹麦

Authorised Representative (AR)

Keymax Technology (Hong Kong) Ltd.

启盈科技 (香港) 有限公司

31508289

Regulatory Timeline

Registration Date

September 02, 2024

Expiry Date

November 19, 2029

Product Models

Titan Inflatable Penile Prosthesis (519180, QN8910, QN8912, QN8914, QN8916, QN8918, QR8106, QR8107, QR8110, 519170, 519300, E17924, E17926, E17928, ER8075, ER8125, 517780, ENR811, ENR814, ENR911, ENR914, ESR811, ESR814, ESR816, ESR818, ESR820, ESR822, ESR911, ESR914, ESR916, ESR918, ESR920, ESR922, QNR810, QNR812, QNR814, QNR816, QNR818, QNR910, QNR912, QNR914, QNR916, QNR918, QSR814, QSR816, QSR818, QSR820, QSR822, QSR914, QSR916, QSR918, QSR920, QSR922, 517750, EN2811, EN2814, EN2911, EN2914, ES2816, ES2818, ES2820, ES2822, ES2916, ES2918, ES2920, ES2922)

泰坦充气假体(519180、QN8910、QN8912、QN8914、QN8916、QN8918、QR8106、QR8107、QR8110、519170、519300、E17924、E17926、E17928、ER8075、ER8125、517780、ENR811、ENR814、ENR911、ENR914、ESR811、ESR814、ESR816、ESR818、ESR818、ESR816、ESR818、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR816、ESR818, ESR818, ESR816, ESR818, ESR818, ESR811 R820, ESR822, ESR911, ESR914, ESR916, ESR918, ESR920, ESR922, QNR810, QNR812, QNR814, QNR816, QNR818, QNR910, QNR912, QNR914, QNR916, QNR918, QSR814, QSR816, QSR818, QSR820, QSR822, QSR914, QSR916, QSR918, QSR920, QSR922, 517750, EN2811, EN2814, EN2911, EN2914, ES2816, ES2818, ES2820, ES2822, ES2916, ES2918, ES2920, ES2922)