Medical Device Division · registration 240296Active

Z-MED II-X Catheter (PDZ700, PDZ701, PDZ702, PDZ703, PDZ704, PDZ705, PDZ706, PDZ707, PDZ708, PDZ709, PDZ710, PDZ711, PDZ712, PDZ713, PDZ714, PDZ715, PDZ716, PDZ717, PDZ718, PDZ719, PDZ720, PDZ721, PDZ722, PDZ723, PDZ724, PDZ725, PDZ726, PDZ727, PDZ728, PDZ729, PDZ730, PDZ731, PDZ732, PDZ733, PDZ734, PDZ735, PDZ736, PDZ737, PDZ738, PDZ739, PDZ740, PDZ741, PDZ742, PDZ743, PDZ744, PDZ745, PDZ746, PDZ747, PDZ748, PDZ749, PDZ750, PDZ751, PDZ752, PDZ753)

Name: Z-MED II-X Catheter (PDZ700, PDZ701, PDZ702, PDZ703, PDZ704, PDZ705, PDZ706, PDZ707, PDZ708, PDZ709, PDZ710, PDZ711, PDZ712, PDZ713, PDZ714, PDZ715, PDZ716, PDZ717, PDZ718, PDZ719, PDZ720, PDZ721, PDZ722, PDZ723, PDZ724, PDZ725, PDZ726, PDZ727, PDZ728, PDZ729, PDZ730, PDZ731, PDZ732, PDZ733, PDZ734, PDZ735, PDZ736, PDZ737, PDZ738, PDZ739, PDZ740, PDZ741, PDZ742, PDZ743, PDZ744, PDZ745, PDZ746, PDZ747, PDZ748, PDZ749, PDZ750, PDZ751, PDZ752, PDZ753) — Medical Device Division 240296
Creator: NuMED, Inc.

Hong KongCatheters, Cardiac, ValvuloplastyClass IVNuMED, Inc.

Verified

Official record identity

MDACS listing number: 240296
Model name: Z-MED II-X Catheter (PDZ700, PDZ701, PDZ702, PDZ703, PDZ704, PDZ705, PDZ706, PDZ707, PDZ708, PDZ709, PDZ710, PDZ711, PDZ712, PDZ713, PDZ714, PDZ715, PDZ716, PDZ717, PDZ718, PDZ719, PDZ720, PDZ721, PDZ722, PDZ723, PDZ724, PDZ725, PDZ726, PDZ727, PDZ728, PDZ729, PDZ730, PDZ731, PDZ732, PDZ733, PDZ734, PDZ735, PDZ736, PDZ737, PDZ738, PDZ739, PDZ740, PDZ741, PDZ742, PDZ743, PDZ744, PDZ745, PDZ746, PDZ747, PDZ748, PDZ749, PDZ750, PDZ751, PDZ752, PDZ753)
Registration date: August 08, 2024
Expiry date: August 07, 2029
Source update date: August 07, 2025
Status: Active

Classification

Risk class: Class IV
Published category: Catheters, Cardiac, Valvuloplasty

Published parties

Registrant / registration holder: True Standard Limited
Manufacturer: NuMED, Inc.

Official description

Catheters, Cardiac, Valvuloplasty

Additional source fields

AMD nomenclature code: 17453
Traditional Chinese local responsible person: 真標有限公司
Local responsible person phone: 26969558
Published manufacturer address: 2880 Main Street, Hopkinton, NY, 12965, United States Of America

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.