current

Circulatory Assist Units, Cardiac, Ventricular循环辅助单元,心脏,心室

This profile provides complete Hong Kong MDACS registration information for Circulatory Assist Units, Cardiac, Ventricular. 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: Circulatory Assist Units, Cardiac, Ventricular

產品資訊： 循环辅助单元,心脏,心室

Device Overview

Hong Kong MDACS registration summary and classification details.

Risk Class

Product Code

10847

Product Code Detail

10847 Circulatory Assist Units, Cardiac, Ventricular

State

current

Status

N/A

DJ Fang

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Pricing

Manufacturer (製造商)

Berlin Heart GmbH

Wiesenweg 10, 12247 Berlin, GERMANY

Wiesenweg 10, 12247 柏林, 德国

Authorised Representative (AR)

IN-MEDI Company Limited

研迪有限公司

35273026

Regulatory Timeline

Registration Date

March 03, 2023

Expiry Date

July 11, 2028

Product Models

Ventricular Assist Device EXCOR VAD System (D03I-001, 1600190, 1600422, P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, P60P-001, P80P-001, P50C-001, P60C-001, P80C-001, P80C-005, C60G-002, C60G-002m, C85G-002, C85G-002m, C60G-004, C60G-004m, C85G-004, C85G-004m, C80G-021, C80G-021m, C80G-040m, C00P-001, C00P-004, C22V-002, C22V-002m, C22V-004, C25V-004, C26V-002, C26V-002m, C23V-004m, C15V-040m, C19V-020, C19V-020m, C14A-040m, C18A-020, C22A-004, C27A-001, A06-009, A09-012, A06-006, A09-009, A12-012, T00L-002, L20H-002x01, L20H-003x01), Mobile driving unit Excor mobil for EXCOR VAD (D01E-001, 1400110, 1400066, 1400165, 1400021, 1600340, 1600342, 1400542, 1400543, 1400581, 1400551, 1400147, 1400516, 1400068, 1400705, 1400017)

心室辅助装置 EXCOR VAD 系统 (D03I-001, 1600190, 1600422, P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, P60P-001, P80P-001, P50C-001, P60C-001, P80C-001, P80C-005, C60G-002, C60G-002m, C85G-002, C85G-002m, C60G-004, C60G-004, C60G-004, C85G-004, C85G-004, C85G-004, C85G-0004, C85G-000 4, C85G-000 04m, C80G-021, C80G-021m, C80G-040m, C00P-001, C00P-004, C22V-002, C22V-002M, C22V-004, C25V-004, C26V-002, C26V-002m, C23V-004m, C15V-040m, C19V-020, C19V-020m, C14A-040m, C18A-020, C22A-004, C27A-001, A06-009, A09-012, A06-006, A09-009, A12-012, T00L-002, L20H-002x01, L20H-003x01), 移动驱动单元 Excor mobil 用于 EXCOR VAD (D01E-001, 1400110, 1400066, 1400165, 1400021, 1600340, 1600342, 1400542, 1400543, 1400581, 1400551, 1400147, 1400516, 1400068, 1400705, 1400017)