Medical Device Division · registration 200337ActiveRoche Diabetes Care
Hong KongLancets, BloodClass IIRoche Diabetes Care GmbH
Official record identity
- MDACS listing number
- 200337
- Model name
- Accu-Chek Softclix Lancet 10's (03157482001), Accu-Chek Softclix Lancet 25's (03307492001), Accu-Chek Softclix Lancet 100's (03307506001), Accu-Chek Softclix Lancet 200's (03307484200), Accu-Chek FastClix Lancets 24's (05981310001), Accu-Chek FastClix Lancets 102's (05981174001), Accu-Chek Softclix (03307450001), Accu-Chek FastClix (07522851172)
- Registration date
- July 21, 2025
- Expiry date
- November 03, 2030
- Source update date
- September 29, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diabetes Care GmbH
Official description
Lancets, Blood
Additional source fields
- AMD nomenclature code
- 10440
- 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
- b
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.