Medical Device Division · registration 241020ActiveTyshak II (SO100, SO086, SO069, SO038, SO037, SO036, SO035, SO034, SO033, SO032, SO031, SO030, SO029, SO021, SO020, SO019, SO018, SO017, SO014, SO009, SO008, SO007, SO004, SO003, SO002, SO001, SN11290, SN013, SN011, SN010, SN009, SN008, SN007, SN006, SN005, SN004, SN003, SN002, SN001, PDC552, PDC551, PDC550, PDC549, PDC548, PDC547, PDC546, PDC545, PDC544, PDC543, PDC542, PDC541, PDC540, PDC539, PDC538, PDC537, PDC536, PDC535, PDC534, PDC533, PDC532, PDC531, PDC530, PDC529, PDC528, PDC527, PDC526, PDC525, PDC524, PDC523, PDC522, PDC521, PDC520, PDC519, PDC518, PDC517, PDC516, PDC515, PDC514, PDC513, PDC512, PDC511, PDC510, PDC509, PDC508, PDC507, PDC506, PDC505, PDC504, PDC503, PDC502, PDC501, PDC500)
Hong KongCatheters, Cardiac, ValvuloplastyClass IVNuMED, Inc.
Official record identity
- MDACS listing number
- 241020
- Model name
- Tyshak II (SO100, SO086, SO069, SO038, SO037, SO036, SO035, SO034, SO033, SO032, SO031, SO030, SO029, SO021, SO020, SO019, SO018, SO017, SO014, SO009, SO008, SO007, SO004, SO003, SO002, SO001, SN11290, SN013, SN011, SN010, SN009, SN008, SN007, SN006, SN005, SN004, SN003, SN002, SN001, PDC552, PDC551, PDC550, PDC549, PDC548, PDC547, PDC546, PDC545, PDC544, PDC543, PDC542, PDC541, PDC540, PDC539, PDC538, PDC537, PDC536, PDC535, PDC534, PDC533, PDC532, PDC531, PDC530, PDC529, PDC528, PDC527, PDC526, PDC525, PDC524, PDC523, PDC522, PDC521, PDC520, PDC519, PDC518, PDC517, PDC516, PDC515, PDC514, PDC513, PDC512, PDC511, PDC510, PDC509, PDC508, PDC507, PDC506, PDC505, PDC504, PDC503, PDC502, PDC501, PDC500)
- Registration date
- September 02, 2024
- Expiry date
- September 01, 2029
- Source update date
- July 30, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
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.