Pure Global
70067
IV
Expired.

Catheter, intravascular, guidingๅฏผ็ฎก,่ก€็ฎกๅ†…,ๅผ•ๅฏผ

This profile provides complete Hong Kong MDACS registration information for Catheter, intravascular, guiding. 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.

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
N/A
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
OrbusNeich Medical B.V.
Orbusneich Medical, B.V.
Authorised Representative (AR)
OrbusNeich Medical Company Limited
ไธš่šๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
31097271/31097216
Regulatory Timeline
Registration Date
September 05, 2007
Expiry Date
September 05, 2012
Product Models
Lumina Guiding Catheter (416-JL-35-00, 416-JL-40-00, 416-JL-45-00, 416-JL-35-0T, 416-JL-40-0T, 416-JL-40-0H, 416-JR-35-00, 416-JR-40-00, 416-JR-45-00, 416-JR-40-0T, 416-JR-40-0H, 416-JR-35-A0, 416-JR-40-A0, 416-JR-45-A0, 416-JR-40-AT, 416-JR-40-AH, 416-AL-10-00, 416-AL-15-00, 416-AL-20-00, 416-AL-10-0T, 416-AL-10-0H, 416-AR-10-00, 416-AR-20-00, 416-AR-10-0H, 416-UB-30-00, 416-UB-35-00, 416-UB-40-00, 416-UB-35-0H, 416-IM-10-00, 416-HS-00-00, 416-LC-00-00, 416-RC-00-00, 416-AL-10-00, 416-AL-15-00, 416-AL-20-00, 416-AL-10-0T, 416-AL-10-0H, 416-AR-10-00, 416-AR-20-00, 416-AR-10-0H, 416-UB-30-00, 416-UB-35-00, 416-UB-40-00, 416-UB-35-0H, 416-IM-10-00, 416-HS-00-00, 416-LC-00-00, 416-RC-00-00, 417-JL-35-00, 417-JL-40-00, 417-JL-45-00, 417-JL-50-00, 417-JL-35-0T, 417-JL-40-0T, 417-JL-40-0H, 417-JR-35-00, 417-JR-40-00, 417-JR-45-00, 417-JR-50-00, 417-JR-40-0T, 417-JR-40-0H, 417-JR-35-A0, 417-JR-40-A0, 417-JR-45-A0, 417-JR-40-AT, 417-JR-40-AH, 417-AL-10-00, 417-AL-15-00, 417-AL-20-00, 417-AR-10-00, 417-AR-20-00, 417-AR-10-0H, 417-AL-10-OT, 417-AL-10-OH, 417-UB-30-00, 417-UB-35-00, 417-UB-40-00, 417-UB-35-0H, 417-IM-10-00, 417-HS-00-00, 417-LC-00-00, 417-RC-00-00)
Lumina ๅผ•ๅฏผๅฏผ็ฎก (416-JL-35-00, 416-JL-40-00, 416-JL-45-00, 416-JL-35-0T, 416-JL-40-0T, 416-JL-40-0H, 416-JR-35-00, 416-JR-40-00, 416-JR-45-00, 416-JR-40-0T, 416-JR-40-0H, 416-JR-35-A0, 416-JR-40-A0, 416-JR-40-A0, 416-JR-40-A0, 416-JR-J0 r-40-A. 0, 416-JR-45-A0, 416-JR-40-AT, 416-JR-40-AH, 416-AL-10-00, 416-AL-15-00, 416-AL-20-00, 416-AL-10-0T, 416-AL-10-0H, 416-AR-10-00, 416-AR-20-00, 416-AR-10-0H, 416-UB-30-00, 416-UB-35-00, 416-UB-40-00, 416-UB-35-0H, 416-IM-10-00, 416-HS-00-00, 416-LC-00-00, 416-RC-00-00, 416-AL-10-00, 416-AL-15-00, 416-AL-20-00, 416-AL-10-0T, 416-AL-10-0H, 416-AR-10-00, 416-AR-20-00, 416-AR-10-0H, 416-UB-30-00, 416-UB-30-00, 416-AL-00, 416-AL-00 UB-35-00, 416-UB-40-00, 416-UB-35-0H, 416-IM-10-00, 416-HS-00-00, 416-LC-00-00, 416-RC-00-00, 417-JL-35-00, 417-JL-40-00, 417-JL-45-00, 417-JL-50-00, 417-JL-35-0T, 417-JL-40-0T, 417-JL-40-0H, 417-JR-35-00, 417-JR-40-00, 417-JR-45-00, 417-JR-50-00, 417-JR-40-0T, 417-JR-40-0H, 417-JR-35-A0, 417-JR-40-A0, 417-JR-45-A0, 417-JR-40-AT, 417-JR-40-AH, 417-AL-10-00, 417-AL-15-00, 417-AL-200 , 417-AL-20 0-00, 417-AR-10-00, 417-AR-20-00, 417-AR-10-0H, 417-AL-10-OT, 417-AL-10-OH, 417-UB-30-00, 417-UB-35-00, 417-UB-40-00, 417-UB-35-0H, 417-IM-10-00, 417-HS-00-00, 417-LC-00-00, 417-RC-00-00)