Eu Mdd Eu Md Class 1 On The Market 🇸🇬 Singapore

CARES4WOUNDS C4W-B

Tetsuyu Healthcare Holdings Pte Ltd · 🇸🇬 Singapore
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-CARES4WOUNDSC4W-BW7
Basic UDI-DI Code
B-CARES4WOUNDSC4W-BW7
Reference
CARES4WOUNDS C4W-B
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The CARES4WOUNDS C4W-B system is a non-contact, digital wound assessment and documentation tool aimed to provide a standardized approach to the monitoring of wound healing progress by medical professionals. It consists of a software application that is used in combination with commercial off-the-shelf (COTS) mobile computing platforms (iPad with 3D structure sensor and iPhone with dual camera) and a web-based software application that is tailored to the mobile platforms. The mobile application uses locked software algorithms to automatically measure the dimensions of wounds, detect wound bed, and classify the tissue types based on epithelization, granulation, necrotic, and slough. The data output is documented in real-time in accordance with the current state-of-the-art clinical workflow to assure consistency and accuracy in wound assessment. The patient data is accessible remotely through a secured web-based portal to improve overall patient management.

CND Nomenclature Codes

Code Description
V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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