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EUDAMED
FDA 510(k)
~1
FDA PMA
GUDID
~399
Country / market
United States
~400
Risk class
Class I
~88
Class IIa
Class IIb
Class III
Class II (US)
~312
More classes (11)
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IVD Annex II List A
IVD Annex II List B
IVD for self-testing
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1,000+ devices found
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Manufacturer: Terrats Medical, S.L.
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
Azure 19.069_02-P10
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 19.093_03-P10
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 19.094_01-P10
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 19.096_05-P10
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 19.095_04-P10
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
DESS Dental Smart Solutions
Terrats Medical SL
Class II
FDA 510(k)
K260564
Active
Cleared 9 Jun 2026
Active
510(k)
510(k)
II
20 variants
See all variants of this device
Azure IBL1480080
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
DESS dental smart solutions 19037
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
DESS dental smart solutions 15004
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 13.025
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 53.155-P5
Terrats Medical SL
Class I
GUDID
on market
None
GUDID
I
DESS dental smart solutions 16025
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
DESS dental smart solutions 14012
Terrats Medical SL
Class I
GUDID
on market
None
GUDID
I
Azure 31.059
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 62.024
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 41.795/3ST
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 20.049ST
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
DESS dental smart solutions 46.492/2
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
DESS dental smart solutions 19006
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
Azure 20.461/2ST
Terrats Medical SL
Class II
GUDID
on market
None
GUDID
II
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