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Results for “Endo files”
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EUDAMED
~1,941
FDA 510(k)
~4
FDA PMA
GUDID
~92
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European Union (all)
~1,941
United States
~96
More countries (7)
Czechia
~1,700
Germany
~179
Spain
~39
Austria
~17
Italy
~3
Netherlands
~2
Finland
~1
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Class I
~116
Class IIa
~1,884
Class IIb
Class III
Class II (US)
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
Status
Status
Regime
Regime
Registry
Registry
Class
Class
Endostep
Shanwei Perfect Medical Instruments Co., Ltd.
·
,
China
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Endodontic Files
Changzhou Sifary Medical Technology Co., Ltd.
·
,
China
CE/MDR
6126956CE01
Expiring
Valid to Aug 2027
Expiring
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
IIa
Endodontic Stainless Steel Hand Files
Diadent Group International
·
,
South Korea
CE/MDR
Active
Regimes:
CE MDR
Registry:
EUDAMED
Class
Class:
I
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