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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
Class III
Class II (US)
10
More classes (11)
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IVD General
IVD Annex II List A
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IVD for self-testing
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Device · Manufacturer · Authorizations
Verified
Verified
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Regime
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Registry
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Class
Sterile Rotary Files
Shenzhen Superline Technology Co., Ltd.
·
,
China
Group of variants
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Root Canal Files, Type K
Union Broach, Div. Moyco Industries, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K822621
Active
Cleared 28 Sep 1982
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
I
Root Canal Files, Type H (Hedstrom
Union Broach, Div. Moyco Industries, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K822622
Active
Cleared 28 Sep 1982
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
I
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