241121
IV
current
Catheters, Vascular, Embolectomy/Thrombectomy导管、血管、栓塞切除术/血栓切除术
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Embolectomy/Thrombectomy. 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: Catheters, Vascular, Embolectomy/Thrombectomy
產品資訊： 导管、血管、栓塞切除术/血栓切除术
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
10714
Product Code Detail
10714 Catheters, Vascular, Embolectomy/Thrombectomy
State
current
Status
N/A
Brand
INDIGO
靛
Manufacturer (製造商)
Penumbra, Inc.
Penumbra,Inc.
United States
美国
One Penumbra Place, Alameda, CA 94502, USA
半影广场一号,阿拉米达,CA 94502,美国
Authorised Representative (AR)
2893 3118
Regulatory Timeline
Registration Date
October 16, 2024
Expiry Date
October 15, 2029
Product Models
Aspiration Catheter (CAT6, CAT6KIT, CAT8TORQ85, CAT8XTORQ115, CAT8TORQ85KIT, CAT8XTORQ115KIT, CATD, CAT7DKIT, LITNG7XTORQ130, LITNG12XTORQ115, LITNG12HTORQ115, LITNGFHT100BER, LITNGFHT100H1, LITNGFHT115BER, LITNGFHT115H1, LITNGFHT80BER, LITNGFHT80H1, LITNGFXT100BER, LITNGFXT100H1, LITNGFXT80BER, LITNGFXT80H1), Separator (SEPD, SEP6, SEP8, SEP7, SEP12, SEP7D), Aspiration Tubing (IST3, IST4)
抽吸导管(CAT6、CAT6KIT、CAT8TORQ85、CAT8XTORQ115、CAT8TORQ85KIT、CAT8XTORQ115KIT、CATD、CAT7DKIT、LITNG7XTORQ130、LITNG12XTORQ115、LITNG12HTORQ115、LITNGFHT100BER、LITNGFHT100H1、LITNGFHT115BER、LITNGFHT115H1、LITNGFHT80BER、LITNGFHT80H1、LITNGFXT100BER、LITNGFXT100H1、LITNGFXT80BER、LITNGFXT80H1)、分离器(SEPD、SEP6、SEP8、SEP7、SEP12、SEP7D)、抽吸管(IST3、IST4)