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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GCA-7200A
FDA 510(k)
FDA Class 2
·Radiology
BioHermes Glycohemoglobin Test Kit
FDA UDI
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.·06935784400071·Glycohemoglobin Test Kit ( Boronate Affinity Ch...
BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
FDA UDI
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.·06935784420260·GluCoA1c Blood Glucose and Glycohemoglobin Anal...
BioHermes Glycohemoglobin Test Kit
FDA UDI
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.·06935784400040·Glycohemoglobin Test Kit ( Boronate Affinity Ch...
BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
FDA UDI
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.·06935784420253·GluCoA1c Blood Glucose and Glycohemoglobin Anal...
BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
FDA UDI
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.·06935784420246·GluCoA1c Blood Glucose and Glycohemoglobin Anal...
BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer
FDA UDI
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.·06935784420239·GluCoA1c Blood Glucose and Glycohemoglobin Anal...
GRAVITY COMPENSATING ACCESSORIES BROWN, HIGH
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·March 11, 2008
GRAVITY COMPESATING ACCESSORY, IOW
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·March 5, 2013
DIGITAL GAMMA CAMERA GCA 501S
FDA 510(k)
FDA Class 2
·Radiology
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
FDA 510(k)
FDA Class 1
·Radiology
JUMBO DIGITAL GAMMACAMERA GCA-90B
FDA 510(k)
FDA Class 2
·Radiology
JUMBO DIGITAL GAMMACAMERA, GCA-901A
FDA 510(k)
FDA Class 1
·Radiology
CAMERA, GCA-10A, LOW ENERGY
FDA 510(k)
FDA Class 1
·Radiology
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Lumipulse G CA 15-3 Calibrators
FDA UDI
FUJIREBIO INC.·04987270230640·
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
FDA 510(k)
FDA Class 2
·Immunology
GRAVITY COMPENSATING ACCESSORY,MEDIUM
FDA Adverse Event
Injury
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code JXG·January 10, 2017
DIGITAL GAMMA CAMERA GCA 601 E
FDA 510(k)
FDA Class 2
·Radiology
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094348934·FRENCH. 110V REDUNDANT