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SANUWAVE dermaPACE® Dermatological extracorporeal shock wave therapy system - HSA Registration DE0506029

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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CLASS B
DE0506029
SANUWAVE dermaPACE® Dermatological extracorporeal shock wave therapy system
HSA Registration Number: DE0506029
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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.

Device 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 Owner
Short Name
SANUWAVE, INC.
Address
3360 Martin Farm Road, Suite 100, Suwanee, GA, 30024 USA, UNITED STATES
Registrant
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #10-02, SINGAPORE 658079
Importer
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