30 results · 18ms · Sources: EU EUDAMED, US FDA

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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

StrokeViewer

Device
EU MDR · 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

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

Medline International B.V.

Importer
🇳🇱 Netherlands·4 Manufacturers

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

Synga medical b.v.

Importer
🇳🇱 Netherlands·10 Manufacturers

BD Kiestra" ReadA; Catalog No.: 446948.

FDA Enforcement
Class II ·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026

AR Experts B.V.

Authorized representative
🇳🇱 Netherlands·65 Manufacturers·3355 Devices