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Materials:
(3 layers of fabric) |
Layer 1: 100% viscose or polyester, non-woven fleece, aluminium vaporized. |
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Layer 2: 100% viscose or 60% viscose combined with 40% polyester non-woven fleece. |
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Layer 3: 100% viscose or hydrophobic polypropylene non-woven fleece. |
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- The middle layer acts as an absorption cushion. |
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- Absorption capacity: +/- 1.400g/m2 |
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- Colour: wound side silvery grey |
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Unit presentation: |
1 aluminized compress or pad, sterile, single-use, in peel pack |
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Primary packaging: |
Unit presentation must mention: manufacturer’s name and/or trademark and address, product description and reference number, "sterile", lot number, expiry date by year and month, "for single use", 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, one (1) box of 10 units. |
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Labelling is the same as 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: |
Must comply with Medical Device Directive 93/42/EEC, mon-adherent wound dressing, sterile Class IIb |