7 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 27, 2023
BE19/819943491
Certificate
MDD Annex II (excluding section 4)·IQ Messenger B.V·SGS Belgium NV·1 Basic UDI-DI
2114129CE01
Certificate
IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI
2114921
Certificate
IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722026 Allura Xper FD10 722028 Allura Xper FD20 722033 Allura Xper FD10 OR Table 722035 Allura Xper FD20 OR Table 722043 Integris Allura 15 & 12 (monoplane) 72246 Poly G - OMCP - VISUB - CCD (H5000)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 27, 2023
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices