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Results for “U FILES”
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EUDAMED
1,055
FDA 510(k) incl. De Novo
2
FDA PMA
GUDID
142
Country / market
European Union (all)
974
United States
144
More countries (7)
Ireland
796
Türkiye
81
Germany
68
Spain
67
France
27
Austria
11
Poland
5
Risk class
Class I
126
Class IIa
1,028
Class IIb
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Class II (US)
10
More classes (11)
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IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
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Device · Manufacturer · Authorizations
Verified
Verified
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Sterile Rotary Files
Shenzhen Superline Technology Co., Ltd.
·
,
China
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Super Files
Shenzhen Denco Medical Co., Ltd.
·
,
China
CE/MDD
Active
Regimes:
CE MDD
Registry:
EUDAMED
Class
Class:
IIa
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