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Plasmapp Co,., Ltd.

FDA 510(k) & PMA Approved 器械 — 8 products

器械总数8
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K231169 STERLINK plus 消毒器与STERLOAD卡式，Tyvek卷材与CI用于STERLINK消毒器，Terragene Bionova SCBI (BT96)，Terragene Bionova Reader Incubators (IC10/20FRLCD，Mini-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)MLR2023-05-25 查看
510(k) K223015 STERLINK™ FPS-15s Plus 消毒器与STERPACK™ plus卡式MLR2023-05-09 查看
510(k) K223025 Tyvek卷材，适用于STERLINK灭菌器，CI认证FRG2023-05-09 查看
510(k) K223023 Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)FRC2023-05-09 查看
510(k) K220345 STERLINK mini 消毒器与STERLOAD mini卡式，Tyvek卷材与CI用于STERLINK消毒器，STERLINK消毒器消毒过程指示器；Terragene Bionova SCBI (BT96)，Terragene Bionova Reader Incubators (IC10/20FRLCD，Mini-Bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)MLR2023-04-14 查看
510(k) K212198 Tyvek® 卷材，用于STERLINKTM 灭菌器，CIFRG2021-10-22 查看
510(k) K212193 Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)FRC2021-10-22 查看
510(k) K212200 STERLINKTM FPS-15s Plus 消毒器与STERLOADTM卡式MLR2021-10-22 查看
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