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Results for “CD138”
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EUDAMED
54
FDA 510(k) incl. De Novo
1
FDA PMA
GUDID
66
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European Union (all)
48
United States
67
More countries (8)
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17
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6
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5
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4
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2
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1
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1
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44
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2
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1
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13
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IVD General
35
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
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5 devices found
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Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
CD138 CM167CK
Biocare Medical, LLC
·
,
United States
CE/IVDD
GUDID
on market
Active
Regimes:
CE IVDD
Registry:
EUDAMED
GUDID
Class
Class:
I
The Orthodontic Store J804K
Young Innovations, Inc.
·
,
United States
GUDID
on market
None
Registry:
GUDID
Class
Class:
II
Invictus 15226-60-065
Alphatec Spine, Inc.
·
,
FDA registration: United States
GUDID
on market
None
Registry:
GUDID
Class
Class:
II
Adapter 9019500
C. R. Bard, Inc.
·
,
United States
GUDID
on market
None
Registry:
GUDID
Class
Class:
I
Surgical Direct SD 14198
Surgical Direct, Inc.
·
,
FDA registration: United States
GUDID
on market
None
Registry:
GUDID
Class
Class:
II
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