Pure Global AI
Medical Device Division · registration 240292Active

Z-MED-X catheter (PDZ400, PDZ401, PDZ402, PDZ403, PDZ404, PDZ405, PDZ406, PDZ407, PDZ408, PDZ409, PDZ410, PDZ411, PDZ412, PDZ413, PDZ414, PDZ415, PDZ416, PDZ417, PDZ418, PDZ419, PDZ420, PDZ421, PDZ422, PDZ423, PDZ424, PDZ425, PDZ426, PDZ427, PDZ428, PDZ429, PDZ430, PDZ431, PDZ432, PDZ433, PDZ434, PDZ435, PDZ436, PDZ437, PDZ438, PDZ439, PDZ440, PDZ441, PDZ442, PDZ443, PDZ444, PDZ445, PDZ446, PDZ447, PDZ448, PDZ449, PDZ450, PDZ451, PDZ452, PDZ453, PDZ454, PDZ455)

Hong KongCatheters, Cardiac, ValvuloplastyClass IVNuMED, Inc.
Official record identity
MDACS listing number
240292
Model name
Z-MED-X catheter (PDZ400, PDZ401, PDZ402, PDZ403, PDZ404, PDZ405, PDZ406, PDZ407, PDZ408, PDZ409, PDZ410, PDZ411, PDZ412, PDZ413, PDZ414, PDZ415, PDZ416, PDZ417, PDZ418, PDZ419, PDZ420, PDZ421, PDZ422, PDZ423, PDZ424, PDZ425, PDZ426, PDZ427, PDZ428, PDZ429, PDZ430, PDZ431, PDZ432, PDZ433, PDZ434, PDZ435, PDZ436, PDZ437, PDZ438, PDZ439, PDZ440, PDZ441, PDZ442, PDZ443, PDZ444, PDZ445, PDZ446, PDZ447, PDZ448, PDZ449, PDZ450, PDZ451, PDZ452, PDZ453, PDZ454, PDZ455)
Registration date
August 08, 2024
Expiry date
August 07, 2029
Source update date
July 30, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: 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.