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EUDAMED
~2,000
FDA 510(k)
~3
FDA PMA
GUDID
~1,249
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European Union (all)
~1,057
United States
~1,251
More countries (18)
France
~394
Germany
~271
Austria
~175
Italy
~60
Poland
~46
Spain
~44
Sweden
~33
Netherlands
~16
Türkiye
~5
Belgium
~4
Denmark
~4
Greece
~2
Finland
~2
Hungary
~2
Bulgaria
~1
Czechia
~1
Croatia
~1
Portugal
~1
Risk class
Class I
~844
Class IIa
~178
Class IIb
~335
Class III
~13
Class II (US)
~506
More classes (11)
Class A
~7
Class B
~4
Class C
Class D
IVD General
~96
IVD Annex II List A
IVD Annex II List B
~16
IVD for self-testing
~1
Active implantable (AIMDD)
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Category (EMDN)
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Verified
Verified
Status
Status
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Regime
Registry
Registry
Class
Class
airlock®
Novastep S.A.S.
·
,
France
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIb
airlock®
Novastep S.A.S.
·
,
France
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
I
Peca® 2.0
Novastep S.A.S.
·
,
France
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIb
airlock®
Novastep S.A.S.
·
,
France
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIa
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