Singapore HSA registration DE0506029
SANUWAVE dermaPACE® Dermatological extracorporeal shock wave therapy system
Singapore·CLASS B·SANUWAVE, INC.·Registered July 30, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0506029
- Registration Date
- July 30, 2021
- Retention Due Date
- July 29, 2025
Product description
The dermaPACE is an Energy generator and control unit for delivery of Extracorporeal Shock Wave (ESW) on acute and chronic defects of the skin and the subcutaneous tissues. Examples of the types of wounds include, but are not limited to: - Diabetic ulcers - Venous and arterial ulcers - Pressure ulcers - Deep partial thickness burns - Wound and skin conditions that can benefit from increased perfusion. The purpose of treating such wounds is to stimulate the body’s healing process to either (1) heal the wound (to point of closure) or the (2) accelerate the healing process to facilitate surgical closure.
Product Owner
- Name
- SANUWAVE, INC.
- Short Name
- SANUWAVE, INC.
- Address
- 3360 Martin Farm Road, Suite 100, Suwanee, GA, 30024 USA, UNITED STATES
Registrant
- Name
- TOPMED PTE. LTD.
- Address
- 10 BUKIT BATOK CRESCENT, THE SPIRE, #10-02, SINGAPORE 658079
Importer
- Name
- TOPMED PTE. LTD.
- Address
- 10 BUKIT BATOK CRESCENT, THE SPIRE, #10-02, SINGAPORE 658079
Model information
- Model Name(s)
- Pullup Probe Cover Kit dermaPACE Applicator dermaPACE Console
- Model Identifier(s)
- 1021206 DAP0332 DEP0330
About this record
Access comprehensive regulatory information for SANUWAVE dermaPACE® Dermatological extracorporeal shock wave therapy system in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506029 and owned by SANUWAVE, INC.. The device was registered on July 30, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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