Occluders, Vascular, Intravascular Embolization, Plug封堵器、血管、血管内栓塞、栓塞

This profile provides complete Hong Kong MDACS registration information for Occluders, Vascular, Intravascular Embolization, Plug. 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: Occluders, Vascular, Intravascular Embolization, Plug

產品資訊： 封堵器、血管、血管内栓塞、栓塞

Device Overview

Hong Kong MDACS registration summary and classification details.

Risk Class

III

Product Code

41447

Product Code Detail

41447 Occluders, Vascular, Intravascular Embolization, Plug

State

current

Status

N/A

DJ Fang

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Pricing

Manufacturer (製造商)

Shape Memory Medical, Inc.

United States

美国

1321 Ridder Park Drive., Suite 10, San Jose, CA 95131, United States of America

1321 Ridder Park Drive., Suite 10, 圣何塞, CA 95131, 美国

Authorised Representative (AR)

Getz Healthcare (Hong Kong) Limited

24849759

Regulatory Timeline

Registration Date

September 09, 2024

Expiry Date

September 08, 2029

Product Models

IMPEDE-FX RapidFill (IMP-FX-12x5), IMPEDE-FX Embolization Plug (IMP-FX-12, IMP-FX-08, IMP-FX-06), IMPEDE Embolization Plug (IMP-10, IMP-07, IMP-05)

IMPEDE-FX RapidFill (IMP-FX-12x5), IMPEDE-FX 栓塞 (IMP-FX-12, IMP-FX-08, IMP-FX-06), IMPEDE 栓塞 (IMP-10, IMP-07, IMP-05)