Medical Device Division · registration 160308ActiveTerumo
Hong KongPositioning AidsClass IVTerumo Cardiovascular Systems Corporation
Official record identity
- MDACS listing number
- 160308
- Model name
- Hercules 360 Universal Stabilizer Arm (T401160), Hercules 3 Universal Stabilizer Arm (T401161), Atlas 360 Positioner Attachment (T401261U), Titan 360 Stabilizer Attachment (T401231U), Atlas Positioner Attachment (T401261), Titan Stabilizer Attachment (T401231), Titan Stabilizer Attachment Long Shaft (T401231LS), StableSoft II Stabilizer (T401244), StableSoft II LS (T401245), Assistant with StableSoft 3L (T401209S), Assistant with StableSoft 3S (T401210S), Assistant with StableSoft 2L (T401211S), Assistant with StableSoft 2S (T401212S), Suture Holder Inserts (T401270)
- Registration date
- June 12, 2026
- Expiry date
- August 23, 2031
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Terumo China (Hong Kong) Limited
- Manufacturer
- Terumo Cardiovascular Systems Corporation
Official description
Positioning Aids
Additional source fields
- AMD nomenclature code
- 16223
- 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
- 125 Blue Ball Road, Elkton, Maryland, 21921, 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.