CELL-DYN Emerald 22

  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Serial Numbers: All instrument with serial numbers below 000700
  • Manufacturer
  • 1 Event

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Abbott CELL-DYN Emerald 22 Instrument, Abbott Laboratories Diagnostics Division
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    CELL-DYN Emerald 22 Analyser with software version v3.0.0. An in vitro diagnostic medical device (IVD)List Number: 09H59-01Serial Number: below 000700ARTG Number: 199356
  • Manufacturer