Medical Device Division · registration 200532ActiveRoche Diabetes Care
Hong KongIVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Glucose, StripIVD Class CRoche Diabetes Care GmbH
Official record identity
- MDACS listing number
- 200532
- Model name
- Accu-Chek Guide test strips (07453710020, 07453736020, 07453744020)
- Registration date
- October 16, 2025
- Expiry date
- January 06, 2031
- Source update date
- December 04, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Glucose, Strip
Official value: C
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diabetes Care GmbH
Official description
IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Whole Blood, Glucose, Strip
Additional source fields
- AMD nomenclature code
- 17419
- 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
- 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.