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Materials: |
Paper or textile strip with adhesive spread in an even layer on one side. |
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Woven or nonwoven textile strip. |
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Adhesive: mixture of rubber, resins and lanolin. |
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Alternative: tape, adhesive, zinc oxide, perforated, with easily detachable protective polyethylene film prevent the passage of air.. |
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Material: textile strip, woven acetate taffeta. |
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Technical Specifications: |
- High cutaneous tolerance. |
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- Non-stretchable. |
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- Able to be torn by hand. |
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- Must adhere strongly when applied to the skin, but can be removed without causing any significant lesions. |
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Colour: white or flesh-coloured. |
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Unit presentation: |
1 roll, not sterile, disposable. |
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Size: length 10m, width 2.5cm or 5cm |
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1 roll (with or without dispensing wheel) in a protective box (6 or 12 rolls per box). |
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Storage: |
Protect from humidity. |
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Temperature: below 25°C. |
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Primary packaging: |
Should indicate: manufacturer’s name and/or trademark. "sterile", lot number, manufacturing date by year and month product description, single CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, indicate number of primary packages. |
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Labelling is the same as that of primary packaging. |
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Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.). |
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Outer packaging: |
Packaging unit: strong carton. |
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Other requirements: |
Meets pharmacopoeia specifications. |