РЗН 2015/3443
Регистрационное удостоверение на медицинское изделие РЗН 2015/3443
Наименование
Имплантаты дентальные IBS с принадлежностямиI. Имплантаты дентальные IBS, в следующих исполнениях:
1. Имплантаты дентальные IBS Regular Fixture:
IBS4007, IBS4009, IBS4011, IBS4013, IBS4015, IBS4507, IBS4509, IBS4511, IBS4513, IBS4515, IBS5007, IBS5009, IBS5011, IBS5013, IBS5015, IBS5507, IBS5509, IBS5511, IBS5513, IBS5515,IBS6007, IBS6009, IBS6011, IBS6013, IBS6015, IBS6507, IBS6509, IBS6511, IBS6513, IBS6515.
2. Имплантаты дентальные IBS N.R.Fixture:
IBS3011, IBS3013, IBS3509, IBS3511, IBS3513.
3. Абатмент IBS: HISS4014, HISS4024, HISS4034, HISS4044, HISS4054, HISS4064, HISS4015, HISS4025, HISS4035,HISS4045, HISS4055, HISS4065, HISS4017, HISS4027, HISS4037, HISS4047, HISS4057, HISS4067, HISS4514, HISS4524, HISS4534, HISS4544, HISS4554, HISS4564, HISS4515, HISS4525, HISS4535, HISS4545,HISS4555, HISS4565, HISS4517, HISS4527, HISS4537, HISS4547, HISS4557, HISS4567, HISS5014, HISS5024, HISS5034, HISS5044, HISS5054, HISS5064, HISS5015, HISS5025,HISS5035, HISS5045, HISS5055, HISS5065, HISS5017, HISS5027, HISS5037, HISS5047, HISS5057,HISS5067, HISS5514, HISS5524, HISS5534, HISS5544, HISS5554, HISS5564, HISS5515, HISS5525,HISS5535, HISS5545, HISS5555, HISS5565, HISS5517, HISS5527, HISS5537, HISS5547, HISS5557,HISS5567, HISS6014, HISS6024, HISS6034, HISS6044, HISS6054, HISS6064, HISS6015, HISS6025, HISS6035, HISS6045, HISS6055, HISS6065, HISS6017, HISS6027, HISS6037, HISS6047, HISS6057, HISS6067, HISS6514, HISS6524, HISS6534, HISS6544, HISS6554, HISS6564, HISS6515, HISS6525, HISS6535, HISS6545, HISS6555, HISS6565, HISS6517, HISS6527, HISS6537, HISS6547, HISS6557, HISS6567.
4. Абатмент заживляющий IBS: HISH4001, HISH4002, HISH4003, HISH4004, HISH4501, HISH4502, HISH4503, HISH4504, HISH5001, HISH5002, HISH5003, HISH5004, HISH 5501, HISH5502, HISH5503, HISH5504, HISH6001, HISH6002, HISH6003, HISH6004.
5. Абатмент парный IBS: OSH4014, OSH4024, OSH4034, OSH4044, OSH4514, OSH4524, OSH4534, OSH4544, OSH5014, OSH5024, OSH5034, OSH5044, OSH5514, OSH5524, OSH5534, OSH5544, OSH6014, OSH6024, OSH6034, OSH6044, OSH6514, OSH6524, OSH6534, OSH6544,OSH4016, OSH4026, OSH4036, OSH4046, OSH4516, OSH4526, OSH4536, OSH4546, OSH5016, OSH5026, OSH5036, OSH5046, OSH5516, OSH5526, OSH5536, OSH5546, OSH6016, OSH6026, OSH6036, OSH6046, OSH6516, OSH6526, OSH6536, OSH6546, OSH4018, OSH4028, OSH4038, OSH4048, OSH4518, OSH4528, OSH4538, OSH4548, OSH5018, OSH5028, OSH5038, OSH5048, OSH5518, OSH5528,OSH5538, OSH5548, OSH6018, OSH6028, OSH6038, OSH6048, OSH6518, OSH6528, OSH6538,OSH6548.
6. Абатмент парный не шестигранной формы IBS: OSN4016, OSN 4026, OSN4036, OSN4046, OSN4516, OSN4526, OSN4536, OSN4546, OSN5016, OSN5026, OSN 5036, OSN5046, OSN5516, OSN5526, OSN5536, OSN5546, OSN6016, OSN6026, OSN6036, OSN 6046,OSN 6516, OSN6526, OSN6536, OSN6546.
7. Абатментугловой IBS: HISA40115, HISA40215, HISA40315, HISA40415, HISA40125, HISA40225, HISA40325, HISA40425(HISA40435X), HISA45115, HISA45215, HISA45315, HISA45415, HISA45125, HISA45225, HISA45325, HISA45425, HISA50115, HISA50215, HISA50315, HISA50415, HISA50125, HISA50225, HISA50325, HISA50425.
8. Абатмент угловой не шестигранной формы IBS: NHSA3115, NHSA3215, NHSA3315, NHSA3415, NHSA3125, NHSA3225, NHSA3325, NHSA 3425, NHSA4115, NHSA4215, NHSA4315, NHSA4415, NHSA4125, NHSA4225, NHSA4325, NHSA4425, NHSA5115, NHSA5215, NHSA5315, NHSA5415, NHSA5125, NHSA5225, NHSA 5325, NHSA5425.
II. Принадлежности:
1.Абатмент-копир IBS:
OSH4016PA, OSH4016TA, OSH4026PA, OSH4026TA, OSH4036PA, OSH4036TA, OSH4046PA, OSH4046TA, OSH4516PA, OSH4516TA, OSH4526PA, OSH4526TA, OSH4536PA, OSH4536TA, OSH4546PA, OSH4546TA, OSH5016PA, OSH5016TA, OSH5026PA(OHS5026PAX), OSH5026TA, OSH5036PA, OSH5036TA, OSH5046PA, OSH5046TA, OSH5516PA, OSH5516TA, OSH5526PA, OSH5526TA, OSH5536PA, OSH5536TA, OSH5546PA, OSH5546TA, OSH6016PA, OSH6016TA, OSH6026PA, OSH6026TA, OSH6036PA, OSH6036TA, OSH6046PA, OSH6046TA, OSH6516PA, OSH6516TA, OSH6526PA, OSH6526TA, OSH6536PA, OSH6536TA, OSH6546PA, OSH6546TA, OSH4014PA, OSH4014TA, OSH4024PA, OSH4024TA, OSH4034PA, OSH4034TA, OSH4044PA, OSH4044TA, OSH4514PA, OSH4514TA, OSH4524PA, OSH4524TA, OSH4534PA, OSH4534TA, OSH4544PA, OSH4544TA, OSH5014PA, OSH5014TA, OSH5024PA, OSH5024TA, OSH5034PA, OSH5034TA, OSH5044PA, OSH5044TA, OSH5514PA,OSH5514TA, OSH5524PA, OSH5524TA, OSH5534PA, OSH5534TA, OSH5544PA, OSH5544TA, OSH6014PA, OSH6014TA, OSH6024PA, OSH6024TA, OSH6034PA, OSH6034TA, OSH6044PA, OSH6044TA, OSH6514PA, OSH6514TA, OSH6524PA, OSH6524TA, OSH6534PA, OSH6534TA, OSH6544PA, OSH6544TA.
2. Абатмент-копир лабораторный IBS: ACSP, ACST, ACHD12.
3. Аналог лабораторный IBS MAC: MACL4.5, MACL5.0, MACL5.5S, MACL6.0S, MACL6.5S, MACL7.0S.
4. Аналог лабораторный IBS: HIAL.
5. Аналог с винтом IBS: SAA45, SAA55, SAA65.
6. Винт IBS: MS15, MS25, MS35, MS45.
7. Винт абатмента: O11AL.
8. Винт восстанавливающий IBS: SAH4501, SAH4502, SAH4503, SAH4504, SAH4505, SAH4506, SAH5501, SAH5502, SAH5503, SAH5504, SAH5505, SAH5506, SAH6501, SAH6502, SAH6503, SAH6504, SAH6505, SAH6506.
9. Винт закрывающий IBS: HISC00.
10. Винт крепления абатмента IBS: SARS1.8.
11. Винт крепления слепочного трансфера IBS: SAIT45, SAIT55, SAIT65.
12. Винт крепления трансфера Pick-Up IBS: SAIP45, SAIP55, SAIP65.
13. Колпачок защитный IBS: SAPC45, SAPC55, SAPC65.
14. Колпачок опоры абатмента IBS: MACCAP4.5, MACCAP5.5, MACCAP6.5.
15. Опора абатмента IBS: MM2502, MM2504, MM2506, MM2508, MM5002, MM5004, MM5006, MM5008, MM7502, MM7504, MM7506, MM7508, MM1002, MM1004, MM1006, MM1008, MAC4501S, MAC4502S, MAC4503S, MAC4505S, MAC4507S, MAC4509S, MAC5501S, MAC5502S, MAC5503S, MAC5505S, MAC5507S, MAC5509S, MAC6501S, MAC6502S, MAC6503S, MAC6505S, MAC6507S, MAC6509S.
16. Трансфер слепочный IBS: HICT40L, HICT40S, HICT45L, HICT45S, HICT50L, HICT50S, HICT55L, HICT55S, HICT60L, HICT60S.
17. Трансфер слепочный IBS Pick-Up: HICР40L, HICР40S, HICР45L, HICР45S, HICР50L, HICР50S, HICР55L, HICР55S, HICР60L, HICР60S.
18. Трансфер слепочный IBS MAC: MACI4.5, MACI5.0, MACI5.5S, MACI6.0S, MACI6.5S, MACI7.0S.
19. Фиксатор с прокладкой IBS: MMRO.
20. Цилиндр выжигаемый IBS: SAC45, SAC55, SAC65.
1. Имплантаты дентальные IBS Regular Fixture:
IBS4007, IBS4009, IBS4011, IBS4013, IBS4015, IBS4507, IBS4509, IBS4511, IBS4513, IBS4515, IBS5007, IBS5009, IBS5011, IBS5013, IBS5015, IBS5507, IBS5509, IBS5511, IBS5513, IBS5515,IBS6007, IBS6009, IBS6011, IBS6013, IBS6015, IBS6507, IBS6509, IBS6511, IBS6513, IBS6515.
2. Имплантаты дентальные IBS N.R.Fixture:
IBS3011, IBS3013, IBS3509, IBS3511, IBS3513.
3. Абатмент IBS: HISS4014, HISS4024, HISS4034, HISS4044, HISS4054, HISS4064, HISS4015, HISS4025, HISS4035,HISS4045, HISS4055, HISS4065, HISS4017, HISS4027, HISS4037, HISS4047, HISS4057, HISS4067, HISS4514, HISS4524, HISS4534, HISS4544, HISS4554, HISS4564, HISS4515, HISS4525, HISS4535, HISS4545,HISS4555, HISS4565, HISS4517, HISS4527, HISS4537, HISS4547, HISS4557, HISS4567, HISS5014, HISS5024, HISS5034, HISS5044, HISS5054, HISS5064, HISS5015, HISS5025,HISS5035, HISS5045, HISS5055, HISS5065, HISS5017, HISS5027, HISS5037, HISS5047, HISS5057,HISS5067, HISS5514, HISS5524, HISS5534, HISS5544, HISS5554, HISS5564, HISS5515, HISS5525,HISS5535, HISS5545, HISS5555, HISS5565, HISS5517, HISS5527, HISS5537, HISS5547, HISS5557,HISS5567, HISS6014, HISS6024, HISS6034, HISS6044, HISS6054, HISS6064, HISS6015, HISS6025, HISS6035, HISS6045, HISS6055, HISS6065, HISS6017, HISS6027, HISS6037, HISS6047, HISS6057, HISS6067, HISS6514, HISS6524, HISS6534, HISS6544, HISS6554, HISS6564, HISS6515, HISS6525, HISS6535, HISS6545, HISS6555, HISS6565, HISS6517, HISS6527, HISS6537, HISS6547, HISS6557, HISS6567.
4. Абатмент заживляющий IBS: HISH4001, HISH4002, HISH4003, HISH4004, HISH4501, HISH4502, HISH4503, HISH4504, HISH5001, HISH5002, HISH5003, HISH5004, HISH 5501, HISH5502, HISH5503, HISH5504, HISH6001, HISH6002, HISH6003, HISH6004.
5. Абатмент парный IBS: OSH4014, OSH4024, OSH4034, OSH4044, OSH4514, OSH4524, OSH4534, OSH4544, OSH5014, OSH5024, OSH5034, OSH5044, OSH5514, OSH5524, OSH5534, OSH5544, OSH6014, OSH6024, OSH6034, OSH6044, OSH6514, OSH6524, OSH6534, OSH6544,OSH4016, OSH4026, OSH4036, OSH4046, OSH4516, OSH4526, OSH4536, OSH4546, OSH5016, OSH5026, OSH5036, OSH5046, OSH5516, OSH5526, OSH5536, OSH5546, OSH6016, OSH6026, OSH6036, OSH6046, OSH6516, OSH6526, OSH6536, OSH6546, OSH4018, OSH4028, OSH4038, OSH4048, OSH4518, OSH4528, OSH4538, OSH4548, OSH5018, OSH5028, OSH5038, OSH5048, OSH5518, OSH5528,OSH5538, OSH5548, OSH6018, OSH6028, OSH6038, OSH6048, OSH6518, OSH6528, OSH6538,OSH6548.
6. Абатмент парный не шестигранной формы IBS: OSN4016, OSN 4026, OSN4036, OSN4046, OSN4516, OSN4526, OSN4536, OSN4546, OSN5016, OSN5026, OSN 5036, OSN5046, OSN5516, OSN5526, OSN5536, OSN5546, OSN6016, OSN6026, OSN6036, OSN 6046,OSN 6516, OSN6526, OSN6536, OSN6546.
7. Абатментугловой IBS: HISA40115, HISA40215, HISA40315, HISA40415, HISA40125, HISA40225, HISA40325, HISA40425(HISA40435X), HISA45115, HISA45215, HISA45315, HISA45415, HISA45125, HISA45225, HISA45325, HISA45425, HISA50115, HISA50215, HISA50315, HISA50415, HISA50125, HISA50225, HISA50325, HISA50425.
8. Абатмент угловой не шестигранной формы IBS: NHSA3115, NHSA3215, NHSA3315, NHSA3415, NHSA3125, NHSA3225, NHSA3325, NHSA 3425, NHSA4115, NHSA4215, NHSA4315, NHSA4415, NHSA4125, NHSA4225, NHSA4325, NHSA4425, NHSA5115, NHSA5215, NHSA5315, NHSA5415, NHSA5125, NHSA5225, NHSA 5325, NHSA5425.
II. Принадлежности:
1.Абатмент-копир IBS:
OSH4016PA, OSH4016TA, OSH4026PA, OSH4026TA, OSH4036PA, OSH4036TA, OSH4046PA, OSH4046TA, OSH4516PA, OSH4516TA, OSH4526PA, OSH4526TA, OSH4536PA, OSH4536TA, OSH4546PA, OSH4546TA, OSH5016PA, OSH5016TA, OSH5026PA(OHS5026PAX), OSH5026TA, OSH5036PA, OSH5036TA, OSH5046PA, OSH5046TA, OSH5516PA, OSH5516TA, OSH5526PA, OSH5526TA, OSH5536PA, OSH5536TA, OSH5546PA, OSH5546TA, OSH6016PA, OSH6016TA, OSH6026PA, OSH6026TA, OSH6036PA, OSH6036TA, OSH6046PA, OSH6046TA, OSH6516PA, OSH6516TA, OSH6526PA, OSH6526TA, OSH6536PA, OSH6536TA, OSH6546PA, OSH6546TA, OSH4014PA, OSH4014TA, OSH4024PA, OSH4024TA, OSH4034PA, OSH4034TA, OSH4044PA, OSH4044TA, OSH4514PA, OSH4514TA, OSH4524PA, OSH4524TA, OSH4534PA, OSH4534TA, OSH4544PA, OSH4544TA, OSH5014PA, OSH5014TA, OSH5024PA, OSH5024TA, OSH5034PA, OSH5034TA, OSH5044PA, OSH5044TA, OSH5514PA,OSH5514TA, OSH5524PA, OSH5524TA, OSH5534PA, OSH5534TA, OSH5544PA, OSH5544TA, OSH6014PA, OSH6014TA, OSH6024PA, OSH6024TA, OSH6034PA, OSH6034TA, OSH6044PA, OSH6044TA, OSH6514PA, OSH6514TA, OSH6524PA, OSH6524TA, OSH6534PA, OSH6534TA, OSH6544PA, OSH6544TA.
2. Абатмент-копир лабораторный IBS: ACSP, ACST, ACHD12.
3. Аналог лабораторный IBS MAC: MACL4.5, MACL5.0, MACL5.5S, MACL6.0S, MACL6.5S, MACL7.0S.
4. Аналог лабораторный IBS: HIAL.
5. Аналог с винтом IBS: SAA45, SAA55, SAA65.
6. Винт IBS: MS15, MS25, MS35, MS45.
7. Винт абатмента: O11AL.
8. Винт восстанавливающий IBS: SAH4501, SAH4502, SAH4503, SAH4504, SAH4505, SAH4506, SAH5501, SAH5502, SAH5503, SAH5504, SAH5505, SAH5506, SAH6501, SAH6502, SAH6503, SAH6504, SAH6505, SAH6506.
9. Винт закрывающий IBS: HISC00.
10. Винт крепления абатмента IBS: SARS1.8.
11. Винт крепления слепочного трансфера IBS: SAIT45, SAIT55, SAIT65.
12. Винт крепления трансфера Pick-Up IBS: SAIP45, SAIP55, SAIP65.
13. Колпачок защитный IBS: SAPC45, SAPC55, SAPC65.
14. Колпачок опоры абатмента IBS: MACCAP4.5, MACCAP5.5, MACCAP6.5.
15. Опора абатмента IBS: MM2502, MM2504, MM2506, MM2508, MM5002, MM5004, MM5006, MM5008, MM7502, MM7504, MM7506, MM7508, MM1002, MM1004, MM1006, MM1008, MAC4501S, MAC4502S, MAC4503S, MAC4505S, MAC4507S, MAC4509S, MAC5501S, MAC5502S, MAC5503S, MAC5505S, MAC5507S, MAC5509S, MAC6501S, MAC6502S, MAC6503S, MAC6505S, MAC6507S, MAC6509S.
16. Трансфер слепочный IBS: HICT40L, HICT40S, HICT45L, HICT45S, HICT50L, HICT50S, HICT55L, HICT55S, HICT60L, HICT60S.
17. Трансфер слепочный IBS Pick-Up: HICР40L, HICР40S, HICР45L, HICР45S, HICР50L, HICР50S, HICР55L, HICР55S, HICР60L, HICР60S.
18. Трансфер слепочный IBS MAC: MACI4.5, MACI5.0, MACI5.5S, MACI6.0S, MACI6.5S, MACI7.0S.
19. Фиксатор с прокладкой IBS: MMRO.
20. Цилиндр выжигаемый IBS: SAC45, SAC55, SAC65.
Номер РУ
РЗН 2015/3443
Дата РУ
23.12.2015
Срок действия РУ
Бессрочно
Номер реестровой записи
8915
Изготовитель
"Иннобиосердж Ко., Лтд"
Фактический адрес изготовителя
, Республика Корея, Innobiosurg Co., Ltd, 44-19, Techno 10-ro, Youseong-gu, Daejeon, Republic of Korea
Юридический адрес изготовителя
, Республика Корея, Innobiosurg Co., Ltd, 44-19, Techno 10-ro, Youseong-gu, Daejeon, Republic of Korea
Код ОКП/ОКПД2
94 3800
Класс риска
2б
Вид
302480
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
Адрес
44-19, Techno 10-ro, Youseong-gu, Daejeon, Republic of Korea
Модели медицинского изделия
Код вида
Наименование модели
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
1. Имплантаты дентальные IBS Regular Fixture: IBS4007, IBS4009, IBS4011, IBS4013, IBS4015, IBS4507, IBS4509, IBS4511, IBS4513, IBS4515, IBS5007, IBS5009, IBS5011, IBS5013, IBS5015, IBS5507, IBS5509, IBS5511, IBS5513, IBS5515,IBS6007, IBS6009, IBS6011, IBS6013, IBS6015, IBS6507, IBS6509, IBS6511, IBS6513, IBS6515.
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
2. Имплантаты дентальные IBS N.R.Fixture: IBS3011, IBS3013, IBS3509, IBS3511, IBS3513.
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
3. Абатмент IBS: HISS4014, HISS4024, HISS4034, HISS4044, HISS4054, HISS4064, HISS4015, HISS4025, HISS4035,HISS4045, HISS4055, HISS4065, HISS4017, HISS4027, HISS4037, HISS4047, HISS4057, HISS4067, HISS4514, HISS4524, HISS4534, HISS4544, HISS4554, HISS4564, HISS4515, HISS4525, HISS4535, HISS4545,HISS4555, HISS4565, HISS4517, HISS4527
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
4. Абатмент заживляющий IBS: HISH4001, HISH4002, HISH4003, HISH4004, HISH4501, HISH4502, HISH4503, HISH4504, HISH5001, HISH5002, HISH5003, HISH5004, HISH 5501, HISH5502, HISH5503, HISH5504, HISH6001, HISH6002, HISH6003, HISH6004.
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
5. Абатмент парный IBS: OSH4014, OSH4024, OSH4034, OSH4044, OSH4514, OSH4524, OSH4534, OSH4544, OSH5014, OSH5024, OSH5034, OSH5044, OSH5514, OSH5524, OSH5534, OSH5544, OSH6014, OSH6024, OSH6034, OSH6044, OSH6514, OSH6524, OSH6534, OSH6544,OSH4016, OSH4026, OSH4036, OSH4046, OSH4516, OSH4526, OSH4536, OSH4546, OSH5016, OSH5026, OSH5
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
6. Абатмент парный не шестигранной формы IBS: OSN4016, OSN 4026, OSN4036, OSN4046, OSN4516, OSN4526, OSN4536, OSN4546, OSN5016, OSN5026, OSN 5036, OSN5046, OSN5516, OSN5526, OSN5536, OSN5546, OSN6016, OSN6026, OSN6036, OSN 6046,OSN 6516, OSN6526, OSN6536, OSN6546.
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
7. Абатментугловой IBS: HISA40115, HISA40215, HISA40315, HISA40415, HISA40125, HISA40225, HISA40325, HISA40425(HISA40435X), HISA45115, HISA45215, HISA45315, HISA45415, HISA45125, HISA45225, HISA45325, HISA45425, HISA50115, HISA50215, HISA50315, HISA50415, HISA50125, HISA50225, HISA50325, HISA50425.
Номенклатурная классификация медицинских изделий по видам
Код
Раздел
Наименование
Описание
Таблица пуста
302480
8. Абатмент угловой не шестигранной формы IBS: NHSA3115, NHSA3215, NHSA3315, NHSA3415, NHSA3125, NHSA3225, NHSA3325, NHSA 3425, NHSA4115, NHSA4215, NHSA4315, NHSA4415, NHSA4125, NHSA4225, NHSA4325, NHSA4425, NHSA5115, NHSA5215, NHSA5315, NHSA5415, NHSA5125, NHSA5225, NHSA 5325, NHSA5425.
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