Bayer Healthcare LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 3 건

  • 모델명 / 제조번호(시리얼번호)
    Test strip lots WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C, WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A, WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F, WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C, WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C, WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A, WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.
  • 제품 설명
    Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; Bayer Healthcare, Mishawaka, IN. U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico).
  • 모델명 / 제조번호(시리얼번호)
    Test strip lots WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C, WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A, WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F, WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C, WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C, WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A, WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.
  • 제품 설명
    Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Bayer Healthcare, Mishawaka, IN. Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and 1825 (Mexico).
  • 모델명 / 제조번호(시리얼번호)
    NO USA Units Affected: Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Canada.
  • 제품 설명
    Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 12 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 모회사 (2017)
  • Source
    NZMMDSA
  • 제조사 주소
    Bayer HealthCare LLC, Diagnostics Div, 1884 Miles Ave., Elkhart IN 46515
  • Source
    USFDA
  • 제조사 모회사 (2017)
  • Source
    AEMPSVFOI
  • 제조사 모회사 (2017)
  • 제조사 대표
    AL-KAMAL Import
  • Source
    SFDA
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