31 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Netherlands
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NICo-Lab B.V.
Manufacturer
🇳🇱 Netherlands·2 Basic UDI-DIs·2 Devices·Kiwa Dare B.V.
ABG LAB EUROPE B.V.
Manufacturer
🇳🇱 Netherlands
IHB OPERATIONS
FDA registration
IHB OPERATIONS·1 product·🇳🇱 Netherlands
StrokeViewer
Device
EU MDR
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Eu Md Class 2b
·NICo-Lab B.V.·On the market·32 countries
StrokeViewer Perfusion
Device
EU MDD
·
Eu Md Class 2a
·NICo-Lab B.V.·On the market·32 countries
NICo-Lab B.V.
FDA registration
NICo-Lab B.V.·2 products·🇳🇱 Netherlands
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
FDA Enforcement
Class II
·Ongoing·IHB OPERATIONS B.V.·April 30, 2025
Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
FDA Enforcement
Class II
·Ongoing·IHB OPERATIONS B.V.·December 13, 2023
StrokeViewer
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·NICo-Lab B.V.·1 device
StrokeViewer Perfusion v1
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·NICo-Lab B.V.·1 device
BD Kiestra" ReadA; Catalog No.: 446948.
FDA Enforcement
Class II
·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026
20M00105CRT01
Certificate
MDD Annex II (excluding section 4)·NICo-Lab B.V.·Kiwa Dare B.V.·1 Basic UDI-DI
ABG Lab Europe B.V.
Authorized representative
🇳🇱 Netherlands
Arseus Lab B.V.
Importer
🇳🇱 Netherlands
Elite Lab b.v.
Importer
🇳🇱 Netherlands
Gratiae Premier Europe BV
Authorized representative
🇳🇱 Netherlands·1 Manufacturer
Axon Lab B. V.
Importer
🇳🇱 Netherlands
Global E-commerce Experts Europe BV
Authorized representative
🇳🇱 Netherlands·6 Manufacturers·46 Devices
Biomet Global Supply Chain Center B.V.
Authorized representative
🇳🇱 Netherlands·19 Manufacturers
Casus Europe B.V.
Authorized representative
🇳🇱 Netherlands·23 Manufacturers·593 Devices