Medical Device Division · registration 100557ActiveSmith & Nephew
Hong KongOrthopedic Internal Fixation SystemsClass IVSmith & Nephew, Inc. Endoscopy Division
Official record identity
- MDACS listing number
- 100557
- Model name
- BioRCI Screw (7207554, 7207555, 7207556, 7207557, 7207558, 7207560, 7207561, 7207562, 7207563, 7207564, 7207565, 7207566, 7207567, 7207568, 7207581, 7207607, 7207608, 7207916, 7207918, 7207919, 7207920, 7207921, 7207923, 7207924)
- Registration date
- August 13, 2025
- Expiry date
- February 13, 2031
- Source update date
- August 20, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Smith & Nephew Limited
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
Official description
Orthopedic Internal Fixation Systems
Additional source fields
- AMD nomenclature code
- 16027
- Traditional Chinese local responsible person
- 施樂輝有限公司
- Local responsible person phone
- 26487700
- Published manufacturer address
- 150 Minuteman Road, Andover, Massachusetts, 01810-1031, USA
- 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.