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EUDAMED
~1,996
FDA 510(k)
~7
FDA PMA
GUDID
~1,331
Country / market
European Union (all)
~1,800
United States
~1,332
More countries (18)
Germany
~923
France
~155
Czechia
~126
Netherlands
~126
Italy
~88
Austria
~80
Finland
~80
Spain
~71
Belgium
~48
Ireland
~32
Poland
~29
Türkiye
~28
Sweden
~10
Hungary
~8
Northern Ireland
~6
Greece
~5
Romania
~5
Cyprus
~4
Risk class
Class I
~625
Class IIa
~821
Class IIb
~150
Class III
~52
Class II (US)
~53
More classes (11)
Class A
~236
Class B
~3
Class C
~4
Class D
IVD General
~53
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
~2
Active implantable (AIMDD)
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Category (EMDN)
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Class
Crown Ns/Efucera Ns 4 Plate Sample
UDI-DI 4SCENZ330ULXC2
Yamahachi Dental Mfg., Co.
·
,
Japan
Class IIa
CE/MDD
GUDID
on market
Active
CE MDD
EUDAMED
GUDID
IIa
75 variants
Crown Ns/Efucera Ns 4 Plate Sample
28*1SETS,O41N3230,UL,B2
Crown Ns/Efucera Ns 4 Plate Sample
28*1SETS,S44SN4130,UL,D2
Crown Ns/Efucera Ns 4 Plate Sample
28*1SETS,S51N4232,UL,C2
See all variants of this device
Crown Px/Efucera Px 4 Plate Sample
UDI-DI 4SCEPZZ45ULXB2
Yamahachi Dental Mfg., Co.
·
,
Japan
Class IIa
CE/MDD
GUDID
on market
Active
CE MDD
EUDAMED
GUDID
IIa
227 variants
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,C42N4128,UL,A1
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S41SN3228,UL,C3
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S42SN3128,UL,A3.5
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S42SN3130,UL,W0.5
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S43SN4128,UL,A1
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S51SN4230,UL,B3
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S61SN61S34,UL,D3
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S71N71L34,UL,D2
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,S81N8136,UL,B2
Crown Px/Efucera Px 4 Plate Sample
28*1SETS,T61SN61S34,UL,A1
See all variants of this device
New Ace/Efucera Ac 4 Plate Sample
UDI-DI 4SNEAZ295ULXB3
Yamahachi Dental Mfg., Co.
·
,
Japan
Class IIa
CE/MDD
GUDID
on market
Active
CE MDD
EUDAMED
GUDID
IIa
138 variants
New Ace/Efucera Ac 4 Plate Sample
28*1SETS,S2S3L30,UL,A1
New Ace/Efucera Ac 4 Plate Sample
28*1SETS,S3S4L30,UL,A1
New Ace/Efucera Ac 4 Plate Sample
28*1SETS,S3S4L30,UL,A2
New Ace/Efucera Ac 4 Plate Sample
28*1SETS,SS2S3L28,UL,A3
See all variants of this device
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