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Which are the first class medical devices

Which are the first class medical devices, Total:18 items.

In the international standard classification, Which are the first class medical devices involves: Medical equipment.


US-CFR-file, Which are the first class medical devices

  • CFR 21-803.33-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.33:If I am a user facility, what must I include when I submit an annual report?
  • CFR 21-803.42-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.42:If I am an importer, what information must I submit in my individual adverse event reports?
  • CFR 21-803.52-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?
  • CFR 21-803.32-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?
  • CFR 21-803.56-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.56:If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
  • CFR 21-803.10-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.10:Generally, what are the reporting requirements that apply to me??
  • CFR 21-803.11-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.11:What form should I use to submit reports of individual adverse events and where do I obtain these forms?
  • CFR 21-803.40-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.40:If I am an importer, what reporting requirements apply to me?
  • CFR 21-803.50-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.50:If I am a manufacturer, what reporting requirements apply to me?
  • CFR 21-803.30-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.30:If I am a user facility, what reporting requirements apply to me?
  • CFR 21-803.53-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.53:If I am a manufacturer, in which circumstances must I submit a 5-day report?
  • CFR 21-803.32-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?
  • CFR 21-803.42-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.42:If I am an importer, what information must I submit in my individual adverse event reports?
  • CFR 21-803.52-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?
  • CFR 21-803.16-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.16:When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?

BE-NBN, Which are the first class medical devices

  • NBN-EN 20594-1-1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements (ISO 594-1:1986)

Danish Standards Foundation, Which are the first class medical devices

  • DS/EN 20594-1:1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements

未注明发布机构, Which are the first class medical devices

  • DIN EN 20594-1 Ber-1:1996 Tapered connections with a 6% (Luer) taper for syringes, cannulas and certain other medical devices – Part 1: General requirements (ISO 594-1: 1986)




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