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Medical Device Division · registration 180529Active

Ad-Tech Medical

Hong KongElectrodes, Neurologic, ElectroencephalographyClass IVAd-Tech Medical Instrument Corporation
Official record identity
MDACS listing number
180529
Model name
Subdural Electrode (DG20A-SP10X-U00, DG32A-SP10X-V00, DS08A-SP10X-000, DS12A-SP10X-000, FG08A-IP10X-0JH, FG08A-SP10X-000, FG08C-SP10X-000, FG16A-SP10X-000, FG16A-SS10X-000, FG16B-SP10X-000, FG20C-SP10X-000, FG20C-SS10X-000, FG32C-SP10X-000, FG32C-SS10X-000, FG32D-SP10X-000, FG32D-SS10X-000, FG35D-SP10X-Z00, FG35E-SP10X-Z00, FG48G-SP10X-000, FG64C-SP10X-000, FG64C-SP10X-020, FG64C-SP10X-0C6, FG64C-SP10X-0CB, FG64C-SS10X-000, FG64D-SP10X-000, FG64D-SS10X-000, IG20C-SP10X-0TB, IG32C-SP10X-0TB, IG64C-SP10X-0TB, IS04R-SP10X-000, IS04R-SS10X-000, IS05R-SP10X-000, IS05R-SS10X-000, IS06R-SP10X-000, IS06R-SS10X-000, IS08R-SP10X-000, IS08R-SS10X-000, MS04R-IP10X-0JH, MS06R-IP10X-000, MS06R-IP10X-0JH, MS08I-SP10X-B00, MS08I-SP10X-F00, MS08L-SP10X-A00, MS08L-SP10X-E00, MS08R-IP10X-0JH, MS08R-SP10X-C00, TS02R-SP10X-000, TS04R-AP10X-0W6, TS04R-SP10X-000, TS06R-AP10X-0W6, TS06R-SP10X-000, TS08R-AP10X-0W6, TS08R-SP10X-000, TS10R-SP10X-000, VG04A-IS00X-0KG, VG04A-IS00X-0KH)
Registration date
October 26, 2023
Expiry date
December 06, 2028
Source update date
January 09, 2024
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Electrodes, Neurologic, Electroencephalography
Published parties
Registrant / registration holder
Tronda Electronics Limited
Official description

Electrodes, Neurologic, Electroencephalography

Additional source fields
AMD nomenclature code
11440
Traditional Chinese local responsible person
創達醫療電子有限公司
Local responsible person phone
26482822
Published manufacturer address
400 West Oakview Parkway, Oak Creek, Wisconsin, 53154, USA
Revision number
a
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.