98 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Netherlands
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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
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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
Norgine BV
Manufacturer
🇳🇱 Netherlands·15 Basic UDI-DIs·15 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
Cavex Holland BV
Manufacturer
🇳🇱 Netherlands·33 Basic UDI-DIs·99 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
Systolé Hardware B.V.
Manufacturer
🇳🇱 Netherlands·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH
easee b.v.
Manufacturer
🇳🇱 Netherlands·TÜV Rheinland LGA Products GmbH
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
Philips Medical Systems Nederland B.V.
Manufacturer
🇳🇱 Netherlands·68 Basic UDI-DIs·355 Devices·DEKRA Certification B.V., BSI Group The Netherlands B.V., and TÜV Rheinland LGA Products GmbH
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
AR Experts B.V.
Authorized representative
🇳🇱 Netherlands·65 Manufacturers·3355 Devices
MOVICOL® Ready to Take
Device
EU MDD
·
Eu Md Class 2b
·Norgine BV·On the market·1 country
MOVICOL®
Device
EU MDD
·
Eu Md Class 2b
·Norgine BV·On the market·1 country