Medical Device Division · registration 241060Active

Tyshak-X (PDC300, PDC301, PDC302, PDC303, PDC304, PDC305, PDC306, PDC307, PDC308, PDC309, PDC310, PDC311, PDC312, PDC313, PDC314, PDC315, PDC316, PDC317, PDC318, PDC319, PDC320, PDC321, PDC322, PDC323, PDC324, PDC325, PDC326, PDC327, PDC328, PDC329, PDC330, PDC331, PDC332, PDC333, PDC334, PDC335, PDC336, PDC337, PDC338, PDC339, PDC340, PDC341, PDC342, PDC343, PDC344, PDC345, PDC346, PDC347)

Name: Tyshak-X (PDC300, PDC301, PDC302, PDC303, PDC304, PDC305, PDC306, PDC307, PDC308, PDC309, PDC310, PDC311, PDC312, PDC313, PDC314, PDC315, PDC316, PDC317, PDC318, PDC319, PDC320, PDC321, PDC322, PDC323, PDC324, PDC325, PDC326, PDC327, PDC328, PDC329, PDC330, PDC331, PDC332, PDC333, PDC334, PDC335, PDC336, PDC337, PDC338, PDC339, PDC340, PDC341, PDC342, PDC343, PDC344, PDC345, PDC346, PDC347) — Medical Device Division 241060
Creator: NuMED, Inc.

Hong KongCatheters, Cardiac, ValvuloplastyClass IVNuMED, Inc.

Verified

Official record identity

MDACS listing number: 241060
Model name: Tyshak-X (PDC300, PDC301, PDC302, PDC303, PDC304, PDC305, PDC306, PDC307, PDC308, PDC309, PDC310, PDC311, PDC312, PDC313, PDC314, PDC315, PDC316, PDC317, PDC318, PDC319, PDC320, PDC321, PDC322, PDC323, PDC324, PDC325, PDC326, PDC327, PDC328, PDC329, PDC330, PDC331, PDC332, PDC333, PDC334, PDC335, PDC336, PDC337, PDC338, PDC339, PDC340, PDC341, PDC342, PDC343, PDC344, PDC345, PDC346, PDC347)
Registration date: September 24, 2024
Expiry date: September 23, 2029
Source update date: July 30, 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.