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Miscellaneous Documentation

Make your selection from the list below. Please allow the entire PDF file to download before browsing or printing.

  • FDA Registration - NY Office

  • FDA Registration - RI Manufacturing

  • Mission Statement

  • ISO 13485-2003 Certificate

  • Canadian CMDCAS 13485-2003 Certificate

  • ISO 9001:2000 Certificate

  • Class IIa Certificate

  • Annex V Certificate

  • Canadian Medical Device Licenses

  • RoHs Compliance Letter

  • Sterilization Instructions


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