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FDA 510(k) incl. De Novo
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Super System
Shanwei Perfect Medical Instruments Co., Ltd.
·
,
China
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Super Flexi Files
Shenzhen Rogin Medical Co., Ltd
·
,
China
Group of variants
CE/MDD
Active
Regimes:
CE MDD
Registry:
EUDAMED
Class
Class:
IIa
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