Medical Device Division · registration 220351ActiveRoche Diabetes Care GmbH
Hong KongNeedles, Injection, Hypodermic, Penlike Cartridge Syringe, ProtectiveClass IIHTL-STREFA S.A.
Official record identity
- MDACS listing number
- 220351
- Model name
- Accu-Fine Pen Needle Type 810 (31Gx5mm, 32Gx4mm)
- Registration date
- June 25, 2025
- Expiry date
- November 03, 2027
- Source update date
- July 02, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Needles, Injection, Hypodermic, Penlike Cartridge Syringe, Protective
Official value: II
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- HTL-STREFA S.A.
Official description
Needles, Injection, Hypodermic, Penlike Cartridge Syringe, Protective
Additional source fields
- AMD nomenclature code
- 23152
- Traditional Chinese local responsible person
- 羅氏診斷(香港)有限公司
- Local responsible person phone
- 24813387
- Published manufacturer address
- Ul. Adamowek 7, 95-035 Ozorkow, Poland
- 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.