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KCI V.A.C. DERMATACโ„ข DRAPE - HSA Registration DE0508418

Access comprehensive regulatory information for KCI V.A.C. DERMATACโ„ข DRAPE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508418 and owned by KCI USA, Inc.. The device was registered on August 21, 2023.

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
DE0508418
KCI V.A.C. DERMATACโ„ข DRAPE
HSA Registration Number: DE0508418
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Product Description

The V.A.C. DERMATAC Drape is an accessory to specific integrated wound management systems. When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0508418
Registration Date
August 21, 2023
Retention Due Date
August 20, 2025
Product Owner
Short Name
KCI USA, Inc.
Address
12930 IH 10 West, San Antonio, TX 78249, UNITED STATES
Registrant
Address
10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Importer
Address
10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Model Information
Model Name(s)
V.A.C. DERMATAC DRAPE
Model Identifier(s)
DTAC10LDP