Medical Device Division · registration 130112ActiveSmith & Nephew
Hong KongNegative-Pressure Wound Therapy SystemsClass IIISmith & Nephew Inc.
Official record identity
- MDACS listing number
- 130112
- Model name
- Renasys EZ PLUS Negative Pressure Wound Therapy System (66800697, 66800423, 66800058, 66800912, 66800913), Renasys EZ MAX Negative Pressure Wound Therapy System (66801309)
- Registration date
- February 21, 2023
- Expiry date
- May 24, 2028
- Source update date
- August 20, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Smith & Nephew Limited
- Manufacturer
- Smith & Nephew Inc.
Official description
Wound Therapy Systems, Negative-Pressure
Additional source fields
- AMD nomenclature code
- 20395
- Traditional Chinese local responsible person
- 施樂輝有限公司
- Local responsible person phone
- 26487700
- Published manufacturer address
- 970 Lake Carillon Drive, Suite 110, St. Petersburg, FL 33716, 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.