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US Medical Devices — FDA Class I · 21 CFR 878.4020

Foam · 6″ × 4″

RashEndZ™ NonWoven Poly GasPort Foam 6" × 4"

Sterile

Flagship occlusive foam with patented GasPort™. DFU · VLU · Pressure · Surgical · IAD · MASD.

Foam · 6″ × 4″

RashEndZ™ NonWoven Poly GasPort Foam 6" × 4"

Non-Sterile

Flagship occlusive foam with patented GasPort™. DFU · VLU · Pressure · Surgical · IAD · MASD.

Foam · 15″ × 4″

RashEndZ™ NonWoven Poly GasPort Foam 15" × 4"

Sterile

Extended coverage for large wound beds, full-length perineal and sacral wounds.

Foam · 15″ × 4″

RashEndZ™ NonWoven Poly GasPort Foam 15" × 4"

Non-Sterile

Extended coverage for large wound beds, full-length perineal and sacral wounds.

Adhesive · 6″ × 3″

RashEndZ™ NonWoven Poly GasPort Adhesive 6" × 3"

Sterile

Infant and pediatric perineal. Self-adhesive, gentle placement. IAD and perineal dermatitis in children.

Adhesive · 15″ × 4″

RashEndZ™ NonWoven Poly GasPort Adhesive 15" × 4"

Sterile

Adult perineal and sacral. Integrated adhesive border — no secondary fixation. IAD · Dermatitis · Sacral pressure injuries.

🌍 Global — EU MDR 2017/745 · REZair™ & oksijen™

REZair™ · EU Class I · Non-Sterile

REZair™ NonWoven Poly GasPort Foam Wound Dressing, 15cm × 10cm

15cm × 10cm · Non-Sterile

CE marked under EU MDR 2017/745 Rule 1. Metric dimensions. Multilingual labeling.

REZair™ · EU Class I · Sterile

REZair™ NonWoven Poly GasPort Foam Wound Dressing, 15cm × 10cm

15cm × 10cm · Sterile

CE marked under EU MDR 2017/745 Rule 1. Metric dimensions. Multilingual labeling.

oksijen™ · EU Class IIa · 2027

oksijen™ Advanced Topical Oxygen Therapy Platform Dressing, 15cm × 10cm

Sterile · Rules 9 & 11

Active oxygen delivery for advanced chronic wound healing. Notified Body retained — process underway.

Five-Patent IP Platform · Protection Through 2046  ·  US 8,978,265 · 2 provisionals filed 2026 · 2 strategic partner patents