Medical Device Division · registration 200533ActiveRoche Diabetes Care
Hong KongAnalyzers, Point-of-Care, Whole Blood, GlucoseIVD Class CRoche Diabetes Care GmbH
Official record identity
- MDACS listing number
- 200533
- Model name
- Accu-Chek Guide mmol/L Set (07400934020)
- Registration date
- May 14, 2026
- Expiry date
- January 06, 2031
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
Official value: C
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diabetes Care GmbH
Official description
Analyzers, Point-of-Care, Whole Blood, Glucose
Additional source fields
- AMD nomenclature code
- 16488
- 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
- c
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.