Medical Device Division · registration 160252ActiveTerumo
Hong KongGuide WiresClass IITerumo Corporation
Official record identity
- MDACS listing number
- 160252
- Model name
- RADIFOCUS Glidewire Advantage (RA*CA35185CM, RA*CA35265CM, RA*CS35185CM, RA*CS35265CM, RA*FA18181CM, RA*FA18301CM, RA*FS18301CM, RA*FA14181CM, RA*FA14301CM, RA*FS14301CM)
- Registration date
- March 26, 2026
- Expiry date
- July 14, 2031
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Terumo China (Hong Kong) Limited
- Manufacturer
- Terumo Corporation
Official description
Guide Wires
Additional source fields
- AMD nomenclature code
- 11925
- Traditional Chinese local responsible person
- 泰爾茂中國(香港)有限公司
- Local responsible person phone
- 28660811/25663393
- Published manufacturer address
- 44-1, 2-chome, Hatagaya, Shibuya-Ku, Tokyo 151-0072, Japan
- Revision number
- d
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.