220318
II
current
Dilators, Surgical, Vascularๆฉๅผ ๅจ, ๅค็ง, ่ก็ฎก
This profile provides complete Hong Kong MDACS registration information for Dilators, Surgical, Vascular. 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: Dilators, Surgical, Vascular
็ขๅ่ณ่จ๏ผ ๆฉๅผ ๅจ, ๅค็ง, ่ก็ฎก
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
11268
Product Code Detail
11268 Dilators, Surgical, Vascular
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Merit Medical Systems, Inc
Merit Medical Systems
Jordan;United States
็บฆๆฆ;็พๅฝ
1600 West Merit Parkway, South Jordan, Utah, 84095, USA
1600 West Merit Parkway, ๅไนไธน, ็นไปๅท, 84095, ็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 14, 2022
Expiry Date
October 14, 2027
Product Models
Merit MAK (Mini Access Kit) (PAKM4NPD4, PAKM4NPD7, PAKM5NPD4, PAKM5NPD7, PAKS4NPD4, PAKS4NPD7, PAKS5NPD4, PAKS5NPD7), PreludeEASE Hydrophilic Sheath Introducer (PAKPHR47NPD4, PAKPHR47NPD7)
ไผ็น้บฆ (่ฟทไฝ ๆฅๅ
ฅๅฅไปถ) (PAKM4NPD4, PAKM4NPD7, PAKM5NPD4, PAKM5NPD7, PAKS4NPD4, PAKS4NPD7, PAKS5NPD4, PAKS5NPD7), PreludeEASEไบฒๆฐดๆคๅฅไป็ปๅจ (PAKPHR47NPD4, PAKPHR47NPD7)