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Results for “SEDA”
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EUDAMED
1,594
FDA 510(k) incl. De Novo
19
FDA PMA
1
GUDID
159
Country / market
European Union (all)
1,564
United States
179
More countries (8)
Czechia
1,281
Spain
202
France
32
Italy
15
Germany
12
Sweden
12
Slovakia
7
Austria
3
Risk class
Class I
1,338
Class IIa
45
Class IIb
213
Class III
27
Class II (US)
109
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
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Regime
Registry
Registry
Class
Class
Sentry Sedate-Basic Sentry-B
Parker Hannifin Corp.
·
,
United States
(FDA applicant)
GUDID
on market
None
Registry:
GUDID
Class
Class:
I
Atramat Seda
Internacional Farmacéutica S.A DE C.V
·
,
FDA registration: United States
Group of variants
GUDID
on market
None
Registry:
GUDID
Class
Class:
II
Sedasys SEDARM01
Ethicon Endo-Surgery, LLC
·
,
United States
GUDID
not on market
Withdrawn
Registry:
GUDID
Class
Class:
III
Sedasys SEDBMU01
Ethicon Endo-Surgery, LLC
·
,
United States
GUDID
not on market
Withdrawn
Registry:
GUDID
Class
Class:
III
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