Manufacturer

Micropointbio

ChinaLegal entities : Micropoint Biotechnologies Co., Ltd.

First countries of placing on the market declared in EUDAMED : France, Germany, Italy, Netherlands, Romania, Sweden, Türkiye

EU representative : Obelis s.a. (Belgium)

Website

10 categories, 23 models including 23 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Hemostasis controls RT & POC	W010302080501	qLabs® APTT Liquid Control QS-9-CL Pro98/79 qLabs® Coag Panel 2 Liquid Control QS-4-CL Pro98/79 qLabs® FIB Controls Level 1 QS-18-CLN98/79 qLabs® FIB Controls Level 2 QS-18-CLP98/79 qLabs® Multi-level Coag Controls QS-6-CL Pro98/79 1 other qLabs® PT-INR Liquid Control QS-1-CL Pro98/79	– 98/79	EUDAMED record Report an error
Chemistry instruments - other	W02010199	qLabs® ElectroMeter Plus Q-2 Plus qLabs® ElectroMeter Q-1 Pro qLabs® ElectroMeter Q-3 Plus qLabs® ElectroMeter Q-3 Pro	A IVDR	EUDAMED record Report an error
Haemostasis RT & POC - other	W0103020899	qLabs® Coag Panel 2 Test Strips QS-4 Pro98/79 qLabs® Coag Panel 4 Test Strips QS-6 Pro98/79 qLabs® FIB Test Strips QS-18 Pro98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	mLabs® ImmunoMeter m-101 mLabs® Smart m-20	A IVDR	EUDAMED record Report an error
Limited panel chemistry analysers - hardware accessories	W0201010280	qLabs® eStation II MBI92 qLabs® eStation MBI91-1	A IVDR	EUDAMED record Report an error
Prothrombin time RT & POC	W0103020801	qLabs® PT-INR Owren (Dry) Test Strips QS-298/79 qLabs® PT-INR Owren (Dry) Test Strips QS-2 Pro98/79	– 98/79	EUDAMED record Report an error
Activated partial thromboplastin time - RT & POC	W0103020802	qLabs® APTT Test Strips QS-9 Pro98/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	mLabs® D-Dimer M101-09100198/79	– 98/79	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	qLabs® Re-Calcification Reagent QS-1-RC Pro	A IVDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	qLabs® ElectroMeter Q-398/79	– 98/79	EUDAMED record Report an error

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