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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Acne Patch; Adhesive Dressing; Hydrocolloid Dressing; Hydrocolloid Dressing, AFD01 (5CM*5CM); Hydrocolloid Dressing, AFD30 (5CM*5CM); Hydrocolloid Foam Dressing; Nonwoven Wound Dressing; POINTMASS Hydrocolloid Acne Patch (Star shaped patch, Colorful)-PM-YDAP14; POINTMASS Hydrocolloid Acne patch (Transparent, Increase absorption)-PM-YDAP02; POINTMASS Hydrocolloid Acne patch (Transparent, Invisible)-PM-YDAP01; POINTMASS Hydrocolloid Acne Patch (Transparent, Invisible)-PM-YDAP11; POINTMASS Hydrocolloid Acne patch(Star shaped patch, Colorful)-PM-YDAP04; POINTMASS Hydrocolloid Acne patch(Transparent, Large area absorption)-PM-YDAP03; POINTMASS Hydrocolloid Dressing, PMH0101(10*10CM); POINTMASS Hydrocolloid Dressing, PMH01011(10*10CM); POINTMASS Hydrocolloid Dressing, PMH0102(10*10CM); POINTMASS Hydrocolloid Dressing, PMH01022(10*10CM); POINTMASS Silicone Dressing, PMS0101 (10*10CM); POINTMASS Silicone Dressing, PMS0102 (10*10CM); POINTMASS Silicone Dressing, PMSS01(17.5cm*17.5CM); POINTMASS Transparent Dressing, PMT0101 (10cm*12CM); POINTMASS Transparent Dressing, PMT0102 (15cm*20CM); Silicone Dressing; TRANSPARENT DRESSING
Classification Name: DRESSING, WOUND, OCCLUSIVE
Product Code: NAD
Device Class: 1
Regulation Number: 878.4020
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ZHEJIANG TOP-MEDICAL MEDICAL DRESSING CO.,LTD.
Registered Establishment Number: 3007028040
Owner/Operator: ZHEJIANG TOP-MEDICAL MEDICAL DRESSING CO.,LTD.
Owner/Operator Number: 9097008
Establishment Operations: Contract Manufacturer; Manufacturer
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