Certificates and Testing
BIOSTER, a.s. is a certified company, holder of ISO 9001 and ISO 13485 certificates, with all its products bearing the CE mark of quality.
Certificates
EC Certificates of products
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EC Certificate n. 09 0519 QS/NB
Traumastem Dent,Traumastem P, Traumastem S Dry, Traumastem TAF, Traumastem TAF Light, single-sided large-area dressing (OKAP), Traumastem Biodres
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EC Certificate n. 09 0615 QS/NC
Traumastem – Biodress Comfort, Biodress Disinfect
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EC Certificate n. 09 0521 QS/NB
ready-to-use sterile dressing, large-area sterile dressing, white sterile sheet
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EC Certificate n. 09 0500 QS/NB
Rescue Sudden birth (sterile package)
EC Design-Examination Certificates
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EC Design-Examination Certificate n. 06 0464 CN/CB
Traumastem P laparoscopic a thoracoscopic set
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EC Design-Examination Certificate n. 09 0520 CN/NB
Traumastem Powder
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EC Design-Examination Certificate n. 10 0108 CN/NB/a
Traumastem TAF impla, Traumastem TAF light, Traumastem Stapler Seam Protection
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EC Design-Examination Certificate n. 08 0197 CN/NB/a
Traumastem Biodress
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EC Design-Examination Certificate n. 09 0616 CN/CB
Traumastem Biodress Disinfect
Tests
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Cytotoxicity in vitro
Traumastem TAF, Traumastem TAF light
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Antimicrobial activity
USP Taf + Taf light
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Antimicrobial activity
USP Biodress
