8 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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ANSER Clavicle Pin
FDA 510(k)
FDA Class 2
·Orthopedic
Scissors, tweezer and safety pins
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Allion BV h.o.d.n. van Heek Medical·4 devices
G1 098021 0005
Certificate
MDD Annex II (excluding section 4)·Pie Medical Imaging B.V.·TÜV SÜD Product Service GmbH·23 Basic UDI-DIs
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.
FDA Enforcement
Class II
·Terminated·Claymount Assembli·July 9, 2014
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
BC Distribution B.V.
Importer
🇳🇱 Netherlands·13 Manufacturers
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers