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Medical Device Division · registration 210407Active

GE

Hong KongSoftware, Digital Radiographic System, MammographicClass IIGE Medical Systems SCS
Official record identity
MDACS listing number
210407
Model name
SenoIris
Registration date
July 22, 2026
Expiry date
December 22, 2031
Source update date
July 24, 2026
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Software, Digital Radiographic System, Mammographic
Published parties
Registrant / registration holder
GE Medical Systems Hong Kong Limited
Official description

Software, Digital Radiographic System, Mammographic

Additional source fields
AMD nomenclature code
26952
Local responsible person phone
21006300
Published manufacturer address
283 rue de la Miniere, 78530 BUC, France
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.