23 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Netherlands
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IQ Messenger B.V
Manufacturer
🇳🇱 Netherlands·1 Basic UDI-DI·1 Device·SGS Belgium NV
IQ Products BV
Manufacturer
🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.
CMV Brite Turbo kit
Device
EU IVDD
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Eu Ivd Annex 2 List B
·IQ Products BV·On the market·5 countries
IQ Messenger Medical
Device
EU MDD
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Eu Md Class 2b
·IQ Messenger B.V·On the market·2 countries
HITAlert Kit
Device
EU IVDD
·
Eu Ivd General
·IQ Products BV·On the market·10 countries
FMH QuikQuant
Device
EU IVDD
·
Eu Ivd General
·IQ Products BV·On the market·9 countries
Fetal Cell Count Kit
Device
EU IVDD
·
Eu Ivd General
·IQ Products BV·On the market·18 countries
CMV Brite Turbo kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·IQ Products BV·1 device
IQ Messenger Medical
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·IQ Messenger B.V·1 device
HITAlert Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·IQ Products BV·1 device
FMH QuikQuant
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·IQ Products BV·1 device
Fetal Cell Count Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·IQ Products BV·1 device
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
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·April 24, 2019
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024
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
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024