0120 Certificate valid until 21 October 2020 0459 Certificate valid until 06 April 2020 0120 Certificate valid until 21 October 2020 Title: MEDICAL DEVI RTIFICATION Group: certified by SGS & G-MED No. Medical Device Description Device 1 Pharmapore 2 Pharmapore PU 3 Pharmapore IV 4 Sterile wound dressing Pharmapore PU IV 5 Pharmapad 6 Pharmapad carbon 7 Protectfilm Family 8 Sterile first aid dressings Cure aid (eye pad ) 9 Sterile theatre incise drapes Incifilm 10 Pharmastrip Sterile skin closure strips 11 Pharmastrip fabric 12 Protectfilm sterile 13 Sterile skin barrier Protectfilm original frame style 14 Protectfilm 7000 15 Absoclear Cushion rings Sterile catheter securement 16 Absoclear cushion tracheostomy dressings 17 Absoclear I.V. dressings 18 Vilowond pad 19 Absorbent non-adherent sterile Vilowond carbon 20 dressing Vilowond carbon plus 21 Vilowond plus 22 Pharmapore gentle 23 Pharmapore PU gentle 24 Pharmapore PU gentle frame style 25 Post-operative dressings with Pharmapore ultra gentle 26 silicon low adherent wound Pharmapore IV gentle 27 contact layer Pharmapore PU IV gentle 28 Pharmapore PU IV gentle frame style 29 Protectfilm gentle 30 Protectfilm gentle frame style 31 Adhesive plasters with silicone Cure-aid gentle 32 Pharma-foam Sterile polyurethane foam 33 Pharma-foam comfort wound dressings 34 Pharma-foam comfort plus 35 Pharma-Algi Family Pharma-Algi pad 36 Sterile hydrogel foam backed wound dressings All wound dressing 37 Non-Woven tissues, saturated in saline wound cleansing solution Salicol Mark Renewal Date 1 P a g e
0459 Certificate valid until 06 April 2020 Title: MEDICAL DEVI RTIFICATION Group: certified by SGS & G-MED 38 Sterile non adherent impregnated gauze dressings Pharmatull 39 Pharmagel 40 Pharmagel comfort 41 Sterile and non-sterile hydrogel Absoclear 42 wound dressings Absoclear comfort 43 Absoclear OTC sterile 44 Absoclear OTC non-sterile 45 Pharma Algi island dressings Sterile alginate wound dressings 46 Pharma Algi OTC 47 Sterile amorphous hydrogel wound dressings Kemagel Amorphous 48 Cure-aid foot care plasters sterile 49 Cure-aid foot care plasters non sterile 50 Cure-aid foot care plasters with glycerol sterile 51 Cure-aid foot care plasters with glycerol non sterile 52 Cure-aid cold sore patches sterile 53 54 55 56 Cure-aid foot care plasters, cold sore patches& cure-aid hydrocolloid dressings & acne patches Cure-aid cold sore patches non sterile Cure-aid cold sore patches with glycerol sterile Cure-aid cold sore patches with glycerol non sterile Cure-aid hydrocolloid dressings sterile 57 Cure-aid hydrocolloid dressings non sterile 58 Cure aid hydrocolloid dressings with glycerol sterile 59 Cure aid hydrocolloid dressings with glycerol non sterile 60 Cure-aid Acne patches 61 Cavidagel sterile hydrogel wound filler with alginate Cavidagel sterile hydrogel wound filler with alginate 62 Polyester mesh coated with low Silotull 63 adherent silicone Silotull one 64 Acrylic fiber superabsorbent Exsorb 65 wound dressing Exsorb laminated with active Exsorb carbon 66 carbon Nonwoven top sheet Exsorb Algi 67 Pharmapore Exsorb 68 Pharmapore Exsorb carbon 69 Pharmapore PU Exsorb 70 Pharmapore PU Exsorb frame style 71 Exsorb with acrylic fibers coated Pharmapore PU IV Exsorb 72 with sodium alginate powder Pharmapore IV Exsorb 73 Pharmapore ultra Exsorb 74 Pharmapore PU Exsorb carbon 75 Pharmapore PU Exsorb carbon frame style 76 Pharmapore ultra Exsorb carbon 2 P a g e
0459 Certificate valid until 06 April 2020 Title: MEDICAL DEVI RTIFICATION Group: certified by SGS & G-MED 77 Adhesive bandage with Cure-aid Exsorb superabsorbent wound pad 78 Exsorb Cure-aid Exsorb dressing strip 79 Polyester mesh coated with Vilowond lipo 80 lipocolloid low adherent, Espuma lipo 81 absorbent matrix, laminated on Espuma lipo comfort 82 absorbent top sheet Pharmapore lipo 83 Pharmapore PU Lipo Polyester mesh coated with 84 Pharmapore PU Lipo frame style lipocolloid low adherent, 85 Pharmapore ultra lipo absorbent matrix, laminated on 86 Pharmapore IV Lipo absorbent top sheet 87 Pharmapore PU IV Lipo 88 Polyester net impregnated combined matrix Pharma Jelly net 89 Adhesive bandage with Cure-aid lipo 90 lipocolloid wound pad Cure-aid lipo dressing strip 91 Espuma gentle 92 Espuma gentle comfort 93 Espuma gentle lite 94 Espuma gentle lite comfort Foam wound dressing with 95 Espuma gentle lite carbon comfort silicone low adherent wound 96 Espuma gentle carbon comfort contact layer 97 Espuma gentle Xtra comfort 98 Espuma gentle lite Xtra comfort 99 Espuma gentle lite carbon Xtra comfort 100 Espuma gentle transfer 101 Sterile amorphous hydrogel wound dressing with alginate Cavidagel burn dressings 102 Espuma non-adhesive 103 Espuma non-adhesive Espuma sealed edges 104 Espuma Carbon sealed edges 105 Espuma adhesive 106 Espuma carbon adhesive 107 Espuma adhesive plus 108 Espuma adhesive dressings Espuma basic 109 Espuma basic adhesive 110 Espuma basic S 111 Espuma basic S adhesive 112 Pharma-Algi F non-adherent Pharma-Algi F 113 dressings Pharma-Algi F carbon 0459 0459 3 P a g e
Certificate valid until 06 April 2020 Title: MEDICAL DEVI RTIFICATION Group: certified by SGS & G-MED 114 Pharma Algi F adhesive 115 Pharma Algi F carbon adhesive 116 Pharma Algi F adhesive film Pharma-Algi F adhesive Island 117 Pharma Algi F carbon adhesive film Dressings with or without 118 Pharma Algi F adhesive film frame style carbon 119 Pharma Algi F carbon adhesive film frame style 120 Pharma Algi F adhesive ultra 121 Pharma Algi F carbon adhesive ultra 122 Pharma-Algi F IV I.V. Dressing with Pharma-Algi 123 Pharma-Algi F IV Film F pad 124 Pharma-Algi F IV Film Frame Style 125 Pharma-Algi F Adhesive Bandages Pharma-Algi F OTC bandages 126 Pharma-Algi F Adhesive Strip 127 Fibrosol Non Adherent Wound Fibrosol Non Adhesive 128 Pad Fibrosol Extra Non Adhesive 129 Fibrosol Adhesive 130 Fibrosol Extra Adhesive 131 Fibrosol Adhesive Film 132 Fibrosol Island Dressings Fibrosol Adhesive Film Frame Style 133 Fibrosol Extra Adhesive Film Frame Style 134 Fibrosol ultra Adhesive 135 Fibrosol Extra Ultra Adhesive 136 Fibrosol foam gentle 137 Fibrosol extra foam gentle Fibrosol foam dressings 138 Fibrosol foam basic 139 Fibrosol extra foam basic 140 Fibrosol IV 141 Fibrosol extra IV Fibrosol IV Dressings 142 Fibrosol IV film 143 Fibrosol Extra IV film 144 Fibrosol adhesive bandages Fibrosol OTC bandages 145 Fibrosol dressings strip 0459 4 P a g e
Title: MEDICAL DEVI RTIFICATION Group: Self-Declaration No Medical Device Description Device Family Types Mark 1 Nose plaster 2 Knee plaster 3 Injection site plaster 4 Fingertip plaster 5 Knuckle (Anchor) 6 Butterfly wound closure strips Non Sterile adhesive plasters 7 Corn plaster 8 Oval patch 9 Feet plaster 10 Cure Aid Dressing strip Cure Aid 11 Cure-Aid non-sterile 12 Metal detectable strips 13 Non Sterile silicon adhesive Cure Aid scare reduction patch Cure Si 3872 14 foam cushions Corn cushions 15 Cotton or spun rayon fabric Wart remover 16 Adhesive bandage with plastic splint Nose Plaster 17 Fabric strapping adhesive +foam padding Skin traction kit 18 Self-adhering silicone adhesive Friction free 19 Kemagel Conductive.. 20 Airoplast 21 Neoplast 22 Waterproof Neoplast 23 Pharmamed 24 Waterproof Pharmamed Adhesive tapes Tapes 25 Silkplast 26 Pharmafix 27 Waterproof Pharmafix 28 Pharmafix PU 29 Elastic Plaster 30 Pharma-KT.. 31 cohesive bandages Vendapress cohesive bandages 32 First-Aid kits.. 33 Alcohol free wipe.. 34 Pharma-UnderCast Pad UnderCast Pad UnderCast Pad 35 Unnaplast Cotton bandage impregnated with creamy zinc oxide paste with or Unnaplast Unnaplast without calamine 36 Cotton/Polyester stretchable bandage Gauza Gauza 37 38 Tubifix fixing systems Tubifix 5 P a g e
Title: MEDICAL DEVI RTIFICATION Group: Self-Declaration 39 Plaster of Paris bandages Pharma POP Plaster of Paris bandages 40 41 42 Advanced hydrogel strip containing natural methanol Kemagel silicone advanced topical gel hydrogel strip Fevokool Silicone gel Kemagel silicone with PU adhesive border 43 Cure-Aid Corn with hydrocolloid adhesive border 44 Corn plaster with salicylic acid Cure-Aid Cure-Aid corn plaster 45 Corn treatment kit 46 Cure-Aid Callus and Wart Removal Disc 47 Callus and Wart Removal Plasters 6 P a g e
Title: MEDICAL DEVI RTIFICATION Group: Cosmetics Product No. Description Product 1 Lanolin Ointment used for dry skin and sore nipples Biosecrets Lanolin ointment 2 Soft gentle non-woven impregnated with especially Wipes (baby & make-up remover& developed lotion antimicrobial) 3 Sticky hydrogel matrix is a classic symptom of dry skin Crack Care 4 The cleansing sheet designed to unclog pores and lift away blackheads Deep cleansing pore strips 5 Cold wax epilatory strip Episera 7 P a g e
Without Title: MEDICAL DEVI RTIFICATION Group: Without EC Certification No. Presence Of Active Ingredient Medical Device Mark 1 Pharma-Jelly Net Silver 2 Espuma Ag 3 Espuma Ag comfort Plus 4 Espuma gentle silver family 5 Pharma-Foam comfort silver plus 6 PharmasuperFoam silver 7 Pharmapad Ag 8 Pharma Jelly net Ag 9 Pharmagel Kemagel Ag 10 Pharmagel Kemagel Ag comfort 11 Kemagel Amorphous Ag 12 Cavidagel Ag 13 Presence of active silver Pharmacoll Ag 14 Pharmacoll Ag Thin 15 Pharmacoll Ag Basic 16 Pharmacoll Ag comfort 17 Pharmacoll Ag OTC Bandages 18 Pharmapad carbon Ag 19 Exsorb Ag Family 20 Exsorb carbon Ag Family 21 Pharma-Algi F Ag 22 Pharma-Algi Ag 23 Fibrosol Ag Family 24 Cure-aid silver 25 Pharmapore Ag family 26 140mg Methyl salicylate+ 1.73 capsicinoid Capsicum Rheumatic Plaster 27 Chlorhexidine Pharmatull Plus 28 Vilowond POVI Gauze 29 Vilowond POVI Pad 30 Cure-aid POVI 31 Cure-aid dressing strip POVI 32 Pharmapore POVI POVI 33 Pharmapore PU POVI 34 Pharmapore PU POVI Frame Style 35 Pharmapore PU I.V. POVI 36 Pharmapore I.V. POVI 37 Pharmapore Ultra POVI 38 Domephin bromide Domephin bromide pad 40 Iodine Incifilm Iodine 41 menthol and Borneol Pharmaband Cool 42 Non-Woven Pad impregnated with isopropyl alcohol Pharmaprep Pad 43 Soft gentle non-woven impregnated with an alcohol free Alcohol Free wipes Lotion 8 P a g e
Title: MEDICAL DEVI RTIFICATION Group: Biocides Products No. Description Product 1 Transparent gel containing ethanol 60% Germifree 2 Mosquito repellent Pharmaplast Mosquito repellent Approved by: Regulatory Affairs Manager Prepared by: Regulatory Affair Member 24/9/2018 9 P a g e