Medical Device Division · registration 241049Active

HCG STAT CalSet (09013296190), Elecsys HCG STAT (08890595190, 08890587190)

Name: HCG STAT CalSet (09013296190), Elecsys HCG STAT (08890595190, 08890587190) — Medical Device Division 241049
Creator: Roche Diagnostics GmbH
Keywords: HCG STAT CalSet (09013296190), Elecsys HCG STAT (08890595190, 08890587190), HCG STAT CalSet (09013296190), Elecsys HCG STAT (08890595190, 08890587190), 241049, IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic GonadotropinIVD Class BRoche Diagnostics GmbH

Verified

Official record identity

MDACS listing number: 241049
Model name: HCG STAT CalSet (09013296190), Elecsys HCG STAT (08890595190, 08890587190)
Registration date: September 24, 2024
Expiry date: September 23, 2029
Source update date: March 31, 2025
Status: Active

Classification

Risk class: IVD Class B
Published category: IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin

Published parties

Registrant / registration holder: Roche Diagnostics (Hong Kong) Limited
Manufacturer: Roche Diagnostics GmbH

Official description

IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin

Additional source fields

AMD nomenclature code: 19123
Traditional Chinese local responsible person: 羅氏診斷(香港)有限公司
Local responsible person phone: 24813387
Published manufacturer address: Sandhofer Strasse 116, 68305 Mannheim, Germany

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.