110 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Netherlands
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EarliQ Drops
Basic UDI-DI
EU MDR
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Eu Md Class 1
·NVV Pharma B.V.·1 device
Medis Medical Imaging Systems bv
Manufacturer
🇳🇱 Netherlands·4 Basic UDI-DIs·4 Devices·SGS Belgium NV and SGS Belgium NV
Serrix B.V
Manufacturer
🇳🇱 Netherlands·SGS Belgium NV
IQ Messenger B.V
Manufacturer
🇳🇱 Netherlands·1 Basic UDI-DI·1 Device·SGS Belgium NV
Nexus Enterprise Diagnostic B.V.
Manufacturer
🇳🇱 Netherlands·SGS Belgium NV
Novioscan B.V.
Manufacturer
🇳🇱 Netherlands·2 Basic UDI-DIs·2 Devices·SGS Belgium NV
ThermaSolutions Europe BV
Manufacturer
🇳🇱 Netherlands·5 Basic UDI-DIs·5 Devices·SGS Belgium NV
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 16, 2019
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
FDA Enforcement
Class II
·Ongoing·Vital Scientific N.V.·December 4, 2019
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
FDA Enforcement
Class II
·Ongoing·Vital Scientific N.V.·October 2, 2019
N.V. Organon
Importer
🇳🇱 Netherlands·1 Manufacturer
Koninklijke Utermöhlen N.V.
Importer
🇳🇱 Netherlands
HOYA Holdings N.V.
Importer
🇳🇱 Netherlands·1 Manufacturer
Koninklijke Utermöhlen N.V.
System producer
🇳🇱 Netherlands
ONWARD MEDICAL N.V.
System producer
🇳🇱 Netherlands