РУ № ФСЗ 2012/13480 от 12 апреля 2022 года
  • ВАШ ПАРТНЕР ПО РЕГИСТРАЦИИ МЕДИЦИНСКИХ ИЗДЕЛИЙ. РАБОТАЕМ БЕЗ ПОСРЕДНИКОВ
  • INFO@GOSZDRAVNADZOR.RU
115487, город Москва

ул. Нагатинская, д. 16

+7 (495) 199-72-57

+7 (999) 000-77-20

РУ № ФСЗ 2012/13480 от 12 апреля 2022 года

  • Главная
  • РУ Росздравнадзора № ФСЗ 2012/13480 от 12 апреля 2022 года
Номер РУ ФСЗ 2012/13480
Класс опасности 1 (медизделие с низким классом потеницального риска применения)
Код ОКП/ОКПД2 32.50.22.125
Дата выдачи РУ 12 апреля 2022 года
Дата окончания РУ РУ действует бессрочно (либо до момента внесения изменений в МИ)
Вид медицинского изделия
262930
Номер записи в реестре 62279
Наименование медицинского изделия Изделия компрессионные для нижних и верхних конечностей в наборах и в отдельных упаковках I. Изделия компрессионные для нижних конечностей в наборах: Набор изделий компрессионных: 2W700, 2W701, 2W702, 2W703, 2W704, 2W705, 2W706, 2W707, 2W708, 2W709, 2W710, 2W711, 2W712, 2W713, 2W714, в составе: — гольфы внешние — 1 шт. — гольфы внутренние — 2 шт. II. Изделия компрессионные для нижних и верхних конечностей в отдельных упаковках: 1. Чулки: 1C100, 1C101, 1C102, 1C103, 1C104, 1C105, 1C106, 1C107, 1C108, 1C109, 1C110, 1C111, 1C112, 1C113, 1C114, 1C115, 1C116, 1C117, 1C118, 1C119, 1C120, 1C121, 1C122, 1C123, 1C124, 1C125, 1C126, 1C127, 1C128, 1C129, 1C130, 1C131, 1C132, 1C133, 1C134, 1C135, 1C136, 1C137, 1C138, 1C139, 1C140, 1C141, 1C142, 1C143, 1C144, 1C145, 1C146, 1C147, 1C148, 1C149, 1C150, 1C151, 1C152, 1C153, 1C154, 1C155, 1C156, 1C157, 1C158, 1C159, 1R160, 1R161, 1R162, 1R163, 1M164, 1M165, 1M166, 1M167, 1M168, 1M169, 1V170, 1V171, 1V172, 1V173, 1V174, 1C175, 1C176, 1C177, 1C178, 1C179, 1P180, 1P181, 1P182, 1P183, 1P184, 1P185, 1P186, 1P187, 1P188, 1P189, 2C100, 2C101, 2C102, 2C103, 2C104, 2C105, 2C106, 2C107, 2C108, 2C109, 2C110, 2C111, 2C112, 2C113, 2C114, 2C115, 2C116, 2R117, 2R118, 2R119, 2R120, 2C121, 2C122, 2C123, 2C124, 2C125, 2C126, 2C127, 2C128, 2C129, 2C130, 2C131, 2C132, 2C133, 2C134, 2C135, 2C136, 2C137, 2C138, 2C139, 2C140, 2C141, 2C142, 2C143, 2C144, 2C145, 2C146, 2C147, 2C148, 2C149, 2C150, 2C151, 2C152, 2C153, 2C154, 2C155, 2C156, 2C157, 2M158, 2M159, 2M160, 2M161, 2M162, 2M163, 2V164, 2V165, 2V166, 2V167, 2V168, 2C169, 2C170, 2C171, 2C172, 2C173, 2C174, 2C175, 2C176, 2C177, 2C178, 2C179, 2P180, 2P181, 2P182, 2P183, 2P184, 2P185, 2P186, 2P187, 2P188, 2P189, 3C100, 3C101, 3C102, 3C103, 3C104, 3C105, 3C106, 3C107, 3C108, 3C109, 3C110, 3C111, 3C112, 3C113, 3C114, 3C115, 3C116, 3C117, 3C118, 3C119, 3C120, 3C121, 3C122, 3C123, 3C124, 3C125, 3P126, 3P127, 3P128, 3P129, 3P130, 3P131, 3P132, 3P133, 3P134, 3P135, 4P100, 4P101, 4P102, 4P103, 4P104, 4P105, 4P106, 4P107, 4P108, 4P109, 0C100, 0C101, 0C102, 0C103, 0C104, 0C105, 0C106, 0C107, 0C108, 0C109, 1C200, 1C201, 1C202, 1C203, 1C204, 1C205, 1C206, 1C207, 1C208, 1C209, 1R210, 1R211, 1R212, 1R213, 1M214, 1M215, 1M216, 1M217, 1M218, 1M219, 1V220, 1V221, 1V222, 1V223, 1V224, 1C225, 1C226, 1C227, 1C228, 1C229, 1C230, 1C231, 1C232, 1C233, 1C234, 1C235, 1C236, 1C237, 1C238, 1C239, 1C240, 1C241, 1C242, 1C243, 1C244, 1C245, 1C246, 1C247, 1C248, 1C249, 1C250, 1C251, 1C252, 1C253, 1C254, 1C255, 1C256, 1C257, 1C258, 1C259, 1C260, 1C261, 1C262, 1C263, 1C264, 1C265, 1C266, 1C267, 1C268, 1C269, 1C270, 1C271, 1C272, 1C273, 1C274, 1C275, 1C276, 1C277, 1C278, 1C279, 1P280, 1P281, 1P282, 1P283, 1P284, 1P285, 1P286, 1P287, 1P288, 1P289, 2C200, 2C201, 2C202, 2C203, 2C204, 2C205, 2C206, 2C207, 2C208, 2C209, 2C210, 2C211, 2C212, 2C213, 2C214, 2C215, 2C216, 2C217, 2C218, 2C219, 2C220, 2C221, 2C222, 2C223, 2C224, 2C225, 2C226, 2C227, 2C228, 2C229, 2C230, 2C231, 2C232, 2C233, 2C234, 2C235, 2R236, 2R237, 2R238, 2R239, 2M240, 2M241, 2M242, 2M243, 2M244, 2M245, 2V246, 2V247, 2V248, 2V249, 2V250, 2C251, 2C252, 2C253, 2C254, 2C255, 2C256, 2C257, 2C258, 2C259, 2C260, 2C261, 2C262, 2C263, 2C264, 2C265, 2C266, 2C267, 2C268, 2C269, 2C270, 2C271, 2C272, 2C273, 2C274, 2C275, 2C276, 2C277, 2C278, 2C279, 2P280, 2P281, 2P282, 2P283, 2P284, 2P285, 2P286, 2P287, 2P288, 2P289, 3C200, 3C201, 3C202, 3C203, 3C204, 3C205, 3C206, 3C207, 3C208, 3C209, 3C210, 3C211, 3C212, 3C213, 3C214, 3C215, 3C216, 3C217, 3C218, 3C219, 3C220, 3C221, 3C222, 3C223, 3C224, 3P225, 3P226, 3P227, 3P228, 3P229, 3P230, 3P231, 3P232, 3P233, 3P234, 4P200, 4P201, 4P202, 4P203, 4P204, 4P205, 4P206, 4P207, 4P208, 4P209, 4P210, 0C200, 0C201, 0C202, 0C203, 0C204, 0C205, 0C206, 0C207, 0C208, 0C209, 0C210, 1A210, 1A211, 1A212, 1A213, 1A214, 1A215, 1A216, 1A217, 1A218, 1A219, 2A210, 2A211, 2A212, 2A213, 2A214, 2A215, 2A216, 2A217, 2A218, 2A219, 3A210, 3A211, 3A212, 3A213, 3A214, 3A215, 3A216, 3A217, 3A218, 3A219, 1A100, 1A101, 1A102, 1A103, 1A104, 1A105, 1A106, 1A107, 1A108, 1A109, 2A100, 2A101, 2A102, 2A103, 2A104, 2A105, 2A106, 2A107, 2A108, 2A109, 3A100, 3A101, 3A102, 3A103, 3A104, 3A105, 3A106, 3A107, 3A108, 3A109, 1S100, 1S101, 1S102, 1S103, 1S104, 1S105, 1S106, 1S107, 1S108, 1S109, 1S110, 1S111, 1S112, 1S113, 1S114, 1S115, 1S116, 1S117, 1S118, 1S119. 2. Колготки: 1C300, 1C301, 1C302, 1C303, 1C304, 1C305, 1C306, 1C307, 1C308, 1C309, 1C310, 1C311, 1C312, 1C313, 1C314, 1C315, 1C316, 1C317, 1C318, 1C319, 1C320, 1C321, 1C322, 1C323, 1C324, 1C325, 1C326, 1C327, 1C328, 1C329, 1C330, 1C331, 1C332, 1C333, 1C334, 1C335, 1C336, 1C337, 1R338, 1R339, 1R340, 1R341, 1R342, 1R343, 1R344, 1R345, 1R346, 1R347, 1R348, 1R349, 1M350, 1M351, 1M352, 1M353, 1M354, 1M355, 1V356, 1V357, 1V358, 1V359, 1V360, 1C361, 1C362, 1C363, 1C364, 1C365, 1C366, 1C367, 1C368, 1C369, 1C370, 1C371, 1C372, 1C373, 1C374, 1C375, 1C376, 1C377, 1C378, 1C379, 1P380, 1P381, 1P382, 1P383, 1P384, 1P385, 1P386, 1P387, 1P388, 1P389, 2C300, 2C301, 2C302, 2C303, 2C304, 2C305, 2C306, 2C307, 2C308, 2C309, 2C310, 2C311, 2C312, 2C313, 2C314, 2C315, 2C316, 2C317, 2C318, 2C319, 2C320, 2C321, 2C322, 2C323, 2C324, 2C325, 2C326, 2C327, 2C328, 2C329, 2C330, 2C331, 2C332, 2C333, 2C334, 2C335, 2C336, 2C337, 2C338, 2C339, 2C340, 2C341, 2C342, 2C343, 2C344, 2C345, 2C346, 2C347, 2C348, 2C349, 2C350, 2C351, 2C352, 2C353, 2C354, 2C355, 2C356, 2C357, 2C358, 2C359, 2C360, 2C361, 2C362, 2C363, 2C364, 2C365, 2C366, 2C367, 2R368, 2R369, 2R370, 2R371, 2M372, 2M373, 2M374, 2M375, 2M376, 2M377, 2V378, 2V379, 2V380, 2V381, 2V382, 2C383, 2C384, 2C385, 2C386, 2C387, 2C388, 2C389, 2P390, 2P391, 2P392, 2P393, 2P394, 2P395, 2P396, 2P397, 2P398, 2P399, 3C300, 3C301, 3C302, 3C303, 3C304, 3C305, 3C306, 3C307, 3C308, 3C309, 3C310, 3C311, 3C312, 3C313, 3C314, 3P315, 3P316, 3P317, 3P318, 3P319, 3P320, 3P321, 3P322, 3P323, 3P324, 4P301, 4P302, 4P303, 4P304, 4P305, 4P306, 4P307, 4P308, 4P309, 4P310, 4P311, 0С300, 0С301, 0С302, 0С303, 0С304, 0С305, 0С306, 0С307, 0С308, 0С309, 0С310, 1С400, 1С401, 1С402, 1С403, 1С404, 1С405, 1С406, 1С407, 1С408, 1С409, 1С410, 1С411, 1С412, 1С413, 1С414, 1С415, 1С416, 1С417, 1P418, 1P419, 2C400, 2C401, 2C402, 2C403, 2C404, 2C405, 2C406, 2C407, 2C408, 2C409, 2C410, 2C411, 2C412, 2C413, 2C414, 2C415, 2C416, 2C417, 2C418, 2P419, 2P420, 0C400, 0C401, 0C402, 0C403, 0C404, 0C405, 0C406, 0C407, 0C408, 0C409. 3. Перчатка: 1L600, 1L601, 1L602, 1L603, 1L604, 1L605, 1L606, 1L607, 1P608, 1P609, 2L600, 2L601, 2L602, 2L603, 2L604, 2L605, 2L606, 2L607, 2P608, 2P609. 4. Рукав (вид 263000): 1L500, 1L501, 1L502, 1L503, 1L504, 1L505, 1L506, 1L507, 1P508, 1P509, 2L500, 2L501, 2L502, 2L503, 2L504, 2L505, 2L506, 2L507, 2P508, 2P509.
Заявитель (держатель РУ) ООО «НИКАМЕД»
Фактический адрес заявителя 127015, Россия, Москва, Бумажный пр-д, д. 14, стр. 2
Юридический адрес заявителя 127015, Россия, Москва, Бумажный пр-д, д. 14, стр. 2
Изготовитель «Рехард Технолоджис ГмбХ»
Фактический адрес изготовителя , Германия, Rehard Technologies GmbH, Potsdamer Straβe 92, 10785 Berlin, Germany
Юридический адрес изготовителя , Германия, Дальнее зарубежье, Rehard Technologies GmbH, Potsdamer Straβe 92, 10785 Berlin, Germany
Производственная площадка 1. Rehard Technologies GmbH, Potsdamer Str. 92, 10785 Berlin, Germany. 2. Elastic Therapy, LLC, 718 Industrial Park Avenue Asheboro, North Carolina, 27205, USA. 3. TEXTIL ELASTICO, S.L.U, Camino Torrefarrera, Km. 0.2,25110, Alpicat, Lleida, Espana. 4. Varimed Medikal San.Tic. Ltd. Sti., Çiftehavuzlar Cad. No:28, Terazidere Mah., Bayrampasa/ Istanbul, Istanbul (Euro Side), 34035, Turkey. 5. SANYLEG SRL, IT-46042 Castel Goffredo (MN) — Via Albania 1/3, Italy.
Информация о регистрации медицинских изделий здесь.