1. Tên cơ sở công bố:
CÔNG TY TNHH Y TẾ HÀ ĐÔ
2. Người đại diện hợp pháp của cơ sở:
3. Trang thiết bị y tế công bố tiêu chuẩn áp dụng:
- Tên trang thiết bị y tế:
Bộ trocar nội soi ổ bụng
- Tên thương mại (nếu có):
- Mã Global Medical Device Nomenclature - GMDN (nếu có):
- Chủng loại: Disposable Laparoscopic Trocar kits
- Mã sản phẩm: 20232021736:
BCT3, BCT5, BCT10, BCT12, BCT15
BCT5/10/10, BCT5/10/12, BCT5/12/12, BCT5/5/10, BCT5/5/12, BCT5/10/10/12, BCT5/5/10/10, BCT5/5/10/12, BCT5/5/12/12, BCT5/5/5/10, BCT10/10/12, BCT10/12/15, BCT5/12/15, BCT5/10/15, BCT5/5/5/12, BCT5/10/12/15, BCT3A, BCT5A, BCT10A, BCT12A, BCT15A, BCT5A/10A/10A, BCT5A/10A/12A, BCT5A/12A/12A, BCT5A/5A/10A, BCT5A/5A/12A BCT5A/10A/10A/12A, BCT5A/5A/10A/10A, BCT5A/5A/10A/12A, BCT5A/5A/12A/12A, BCT5A/5A/5A/10A, BCT10A/10A/12A, BCT10A/12A/15A, BCT5A/12A/15A, BCT5A/10A/15A, BCT5A/5A/5A/12A, BCT5A/10A/12A/15A
20242020093:
BCF001, BCF002, BCF003, BCF004, BCF005, BCF006, BCF007, BCF008, BCF009,
BCF010, BCF011, BCF012, BCF013, BCF014, BCF015, BCF016, BCF017, BCF018,
BCF019, BCF020, BCF021, BCF022, BCF023, BCF024, BCF025, BCF026, BCF027,
BCF028, BCF029, BCF030, BCF031, BCF032, BCF033, BCF034, BCF035, BCF036,
BCF037, BCF038, BCF039, BCF040, BCF041, BCF042, BCF043, BCF044, BCF045,
BCF046, BCF047, BCF048, BCF049, BCF050, BCF051, BCF052, BCF053, BCF054,
BCF055, BCF056, BCF057, BCF058, BCF059, BCF060, BCF061, BCF062, BCF063,
BCF064, BCF065, BCF066, BCF067, BCF068, BCF069, BCF070, BCF071, BCF072,
BCF073, BCF074, BCF075, BCF076, BCF077, BCF078, BCF079, BCF080, BCF081,
BCF082, BCF083, BCF084, BCF085, BCF086, BCF087, BCF088, BCF089, BCF090,
BCF091, BCF092, BCF093, BCF094, BCF095, BCF096, BCF097, BCF098, BCF099,
BCF100, BCF101, BCF102, BCF103, BCF104, BCF105, BCF106, BCF107, BCF108,
BCF109, BCF110, BCF111, BCF112, BCF113, BCF114, BCF115, BCF116, BCF117,
BCF118, BCF119, BCF120, BCF121, BCF122, BCF123, BCF124, BCF125, BCF126,
BCF127, BCF128, BCF129, BCF130, BCF131, BCF132, BCF133, BCF134, BCF135,
BCF136, BCF137, BCF138, BCF139, BCF140, BCF141, BCF142, BCF143, BCF144,
BCF145, BCF146, BCF147, BCF148, BCF149, BCF150, BCF151, BCF152, BCF153,
BCF154, BCF155, BCF156, BCF157, BCF158, BCF159, BCF160, BCF161, BCF162,
BCF163, BCF164, BCF165, BCF166, BCF167, BCF168, BCF169, BCF170, BCF171,
BCF172
BCFQ001, BCFQ002, BCFQ003, BCFQ004, BCFQ005, BCFQ006, BCFQ007, BCFQ008,
BCFQ009, BCFQ010, BCFQ011, BCFQ012, BCFQ013, BCFQ014, BCFQ015, BCFQ016,
BCFQ017, BCFQ018, BCFQ019, BCFQ020, BCFQ021, BCFQ022, BCFQ023, BCFQ024,
BCFQ025, BCFQ026, BCFQ027, BCFQ028, BCFQ029, BCFQ030, BCFQ031, BCFQ032,
BCFQ033, BCFQ034, BCFQ035, BCFQ036, BCFQ037, BCFQ038, BCFQ039, BCFQ040,
BCFQ041, BCFQ042, BCFQ043, BCFQ044, BCFQ045, BCFQ046, BCFQ047, BCFQ048,
BCFQ049, BCFQ050, BCFQ051, BCFQ052, BCFQ053, BCFQ054, BCFQ055, BCFQ056,
BCFQ057, BCFQ058, BCFQ059, BCFQ060, BCFQ061, BCFQ062, BCFQ063, BCFQ064,
BCFQ065, BCFQ066, BCFQ067, BCFQ068, BCFQ069, BCFQ070, BCFQ071, BCFQ072,
BCFQ073, BCFQ074, BCFQ075, BCFQ076, BCFQ077, BCFQ078, BCFQ079, BCFQ080,
BCFQ081, BCFQ082, BCFQ083, BCFQ084, BCFQ085, BCFQ086, BCFQ087, BCFQ088,
BCFQ089, BCFQ090, BCFQ091, BCFQ092, BCFQ093, BCFQ094, BCFQ095, BCFQ096,
BCFQ097, BCFQ098, BCFQ099, BCFQ100, BCFQ101, BCFQ102, BCFQ103, BCFQ104,
BCFQ105, BCFQ106, BCFQ107, BCFQ108, BCFQ109, BCFQ110, BCFQ111, BCFQ112,
BCFQ113, BCFQ114, BCFQ115, BCFQ116, BCFQ117, BCFQ118, BCFQ119, BCFQ120,
BCFQ121, BCFQ122, BCFQ123, BCFQ124, BCFQ125, BCFQ126, BCFQ127, BCFQ128,
BCFQ129, BCFQ130, BCFQ131, BCFQ132, BCFQ133, BCFQ134, BCFQ135, BCFQ136,
BCFQ137, BCFQ138, BCFQ139, BCFQ140, BCFQ141, BCFQ142, BCFQ143, BCFQ144,
BCFQ145, BCFQ146, BCFQ147, BCFQ148, BCFQ149, BCFQ150, BCFQ151, BCFQ152,
BCFQ153, BCFQ154, BCFQ155, BCFQ156, BCFQ157, BCFQ158, BCFQ159, BCFQ160,
BCFQ161, BCFQ162, BCFQ163, BCFQ164, BCFQ165, BCFQ166, BCFQ167, BCFQ168,
BCFQ169, BCFQ170, BCFQ171, BCFQ172, BCFQ173, BCFQ174, BCFQ175, BCFQ176,
BCFQ177, BCFQ178, BCFQ179, BCFQ180, BCFQ181, BCFQ182, BCFQ183, BCFQ184,
BCFQ185, BCFQ186, BCFQ187, BCFQ188, BCFQ189, BCFQ190, BCFQ191, BCFQ192,
BCFQ193, BCFQ194, BCFQ195, BCFQ196, BCFQ197, BCFQ198, BCFQ199, BCFQ200,
BCFQ201, BCFQ202, BCFQ203, BCFQ204, BCFQ205, BCFQ206, BCFQ207, BCFQ208,
BCFQ209, BCFQ210, BCFQ211, BCFQ212, BCFQ213, BCFQ214, BCFQ215, BCFQ216,
BCFQ217, BCFQ218, BCFQ219, BCFQ220, BCFQ221, BCFQ222, BCFQ223, BCFQ224,
BCFQ225, BCFQ226, BCFQ227, BCFQ228, BCFQ229, BCFQ230, BCFQ231, BCFQ232,
BCFQ233, BCFQ234, BCFQ235, BCFQ236, BCFQ237, BCFQ238, BCFQ239, BCFQ240,
BCFQ241, BCFQ242, BCFQ243, BCFQ244, BCFQ245, BCFQ246, BCFQ247, BCFQ248,
BCFQ249, BCFQ250, BCFQ251, BCFQ252, BCFQ253, BCFQ254, BCFQ255, BCFQ256,
BCFQ257, BCFQ258, BCFQ259, BCFQ260, BCFQ261, BCFQ262, BCFQ263, BCFQ264,
BCFQ265, BCFQ266, BCFQ267, BCFQ268, BCFQ269, BCFQ270, BCFQ271, BCFQ272,
BCFQ273, BCFQ274, BCFQ275, BCFQ276, BCFQ277, BCFQ278, BCFQ279, BCFQ280,
BCFQ281, BCFQ282, BCFQ283, BCFQ284, BCFQ285, BCFQ286, BCFQ287, BCFQ288,
BCFQ289, BCFQ290, BCFQ291, BCFQ292, BCFQ293, BCFQ294, BCFQ295, BCFQ296,
BCFQ297, BCFQ298, BCFQ299, BCFQ300, BCFQ301, BCFQ302, BCFQ303, BCFQ304,
BCFQ305, BCFQ306, BCFQ307, BCFQ308, BCFQ309, BCFQ310, BCFQ311, BCFQ312,
BCFQ313, BCFQ314, BCFQ315, BCFQ316, BCFQ317, BCFQ318, BCFQ319, BCFQ320,
BCFQ321, BCFQ322, BCFQ323, BCFQ324, BCFQ325, BCFQ326, BCFQ327, BCFQ328,
BCFQ329, BCFQ330, BCFQ331, BCFQ332, BCFQ333, BCFQ334, BCFQ335, BCFQ336,
BCFQ337, BCFQ338, BCFQ339, BCFQ340, BCFQ341, BCFQ342, BCFQ343, BCFQ344,
BCFQ345, BCFQ346, BCFQ347, BCFQ348, BCFQ349, BCFQ350, BCFQ351, BCFQ352
- Quy cách đóng gói (nếu có):
- Loại trang thiết bị y tế:
TBYT Loại B
- Mục đích sử dụng:
Sử dụng trong quá trình thăm khám và phẫu thuật nội soi ổ bụng, nhằm chọc xuyên thành bụng để thiết lập kênh thao tác cho phẫu thuật nội soi
- Tên cơ sở sản xuất:
Bonnie Medical Device Technology (Changzhou) Co.,Ltd
- Địa chỉ cơ sở sản xuất:
5th Floor, A1 Block, Hutang Technology Industrial Park, Hutang Town, Wujin District, Changzhou City, Jiangsu Province, China,
- Tiêu chuẩn chất lượng sản phẩm áp dụng:
ISO13485:2016
4. Đối với trang thiết bị y tế chứa chất ma túy, tiền chất (nếu có):
5. Thông tin về chủ sở hữu trang thiết bị y tế:
6. Thông tin về cơ sở bảo hành:
7. Số công bố đủ điều kiện sản xuất đối với trang thiết bị y tế sản xuất trong nước:
1. Nội dung thông tin công bố là chính xác, hợp pháp và theo đúng quy định. Nếu có sự giả mạo, không đúng sự thật cơ sở xin chịu hoàn toàn trách nhiệm và sẽ bị xử lý theo quy định của pháp luật.
2. Bảo đảm chất lượng và lưu hành trang thiết bị y tế theo đúng hồ sơ đã công bố.
3. Cập nhật các thay đổi liên quan đến hồ sơ công bố tiêu chuẩn áp dụng theo quy định.
