EUDAMED update: Jan 10, 2024

Micropoint Biotechnologies Co., Ltd.

CN-MF-000007991

Active29 devices

Address: 3-5F, Building 1, Runheng Electronics Factory, 518101 Shenzhen
Role: Manufacturer
Date of registration: Jun 22, 2021
Country: China

Micropoint Biotechnologies Co., Ltd. is a medical device manufacturer registered in EUDAMED. The company has 29 devices on the EU market across 6 countries. Headquartered in Shenzhen, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Micropoint

: CN-MF-000007991
Role: Manufacturer
Country: China
Organization name: Micropoint Biotechnologies Co., Ltd.
EU VAT number: 91440300664196632N
Date of registration: Jun 22, 2021

Contact details for Micropoint

Phone: +86 755 21600849
Email: h.wang@micropointbio.cn
Website: www.micropointbio.com
Address: 3-5F, BUILDING 1, RUNHENG ELECTRONICS FACTORY LIUXIAN 2 ROAD, XINAN STREET, BAONAN DISTRICT 518101 SHENZHEN CHINA

Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Officers and regulatory representatives of Micropoint

WANG Huan
Ensuring: the conformity of the devices is appropriately checked before a device is released; the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; the post-market surveillance obligations are complied; the reporting obligations are fulfilled.
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Connected operators

Importers

5 EU importers place this manufacturer's devices

Data export

Export the 29 devices of Micropoint

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
mLabs® BNP	mLabs® BNP	`M101-091004`	`06974703166322`	1	On the market
mLabs® Cardiac Panel 3	mLabs® Cardiac Panel 3	`M101-091011`	`06974703166353`	1	On the market
mLabs® CRP	mLabs® CRP	`M101-091015`	`06974703166377`	1	On the market
mLabs® D-Dimer	mLabs® D-Dimer	`M101-091001`	`06974703166308`	1	On the market
mLabs® Multi-level BNP Controls	mLabs® Multi-level BNP Controls	`M101-091008`	`06974703166438`	1	On the market
mLabs® Multi-level Cardiac Panel 3 Controls	mLabs® Multi-level Cardiac Panel 3 Controls	`M101-091012`	`06974703166452`	1	On the market
mLabs® Multi-level CRP Controls	mLabs® Multi-level CRP Controls	`M101-091025`	`06974703166513`	1	On the market
mLabs® Multi-level D-Dimer Controls	mLabs® Multi-level D-Dimer Controls	`M101-091002`	`06974703166414`	1	On the market
mLabs® Multi-level NT-proBNP Controls	mLabs® Multi-level NT-proBNP Controls	`M101-091013`	`06974703166469`	1	On the market
mLabs® Multi-level PCT Controls	mLabs® Multi-level PCT Controls	`M101-091009`	`06974703166445`	1	On the market
mLabs® Multi-level TnI Controls	mLabs® Multi-level TnI Controls	`M101-091007`	`06974703166421`	1	On the market
mLabs® NT-proBNP	mLabs® NT-proBNP	`M101-091005`	`06974703166339`	1	On the market
mLabs® PCT	mLabs® PCT	`M101-091010`	`06974703166346`	1	On the market
mLabs® Troponin I	mLabs® Troponin I	`M101-091003`	`06974703166315`	1	On the market
qLabs® APTT Liquid Control	qLabs® APTT Liquid Control	`QS-9-CL Pro`	`06974703160207`	1	On the market
qLabs® APTT Test Strips	qLabs® APTT Test Strips	`QS-9 Pro`	`06974703160160`	1	On the market
qLabs® Coag Panel 2 Liquid Control	qLabs® Coag Panel 2 Liquid Control	`QS-4-CL Pro`	`06974703160191`	1	On the market
qLabs® Coag Panel 2 Test Strips	qLabs® Coag Panel 2 Test Strips	`QS-4 Pro`	`06974703160177`	1	On the market
qLabs® Coag Panel 4 Test Strips	qLabs® Coag Panel 4 Test Strips	`QS-6 Pro`	`06974703160757`	1	On the market
qLabs® ElectroMeter	qLabs® ElectroMeter	`Q-3`	`06974703168173`	1	On the market
qLabs® FIB Test Strips	qLabs® FIB Test Strips	`QS-18 Pro`	`06974703160269`	1	On the market
qLabs® Multi-level Coag Controls	qLabs® Multi-level Coag Controls	`QS-6-CL Pro`	`06974703160764`	1	On the market
qLabs® PT-INR Liquid Control	qLabs® PT-INR Liquid Control	`QS-1-CL Pro`	`06974703160184`	1	On the market
qLabs® PT-INR Owren (Dry) Test Strips	qLabs® PT-INR Owren (Dry) Test Strips	`QS-2 Pro`	`06974703160795`	1	On the market
qLabs® PT-INR Owren (Dry) Test Strips	qLabs® PT-INR Owren (Dry) Test Strips	`QS-2`	`06974703160788`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
mLabs® BNP	mLabs® BNP	`M101-091004`	`06974703166322`	1	On the market
mLabs® Cardiac Panel 3	mLabs® Cardiac Panel 3	`M101-091011`	`06974703166353`	1	On the market
mLabs® CRP	mLabs® CRP	`M101-091015`	`06974703166377`	1	On the market
mLabs® D-Dimer	mLabs® D-Dimer	`M101-091001`	`06974703166308`	1	On the market
mLabs® Multi-level BNP Controls	mLabs® Multi-level BNP Controls	`M101-091008`	`06974703166438`	1	On the market
mLabs® Multi-level Cardiac Panel 3 Controls	mLabs® Multi-level Cardiac Panel 3 Controls	`M101-091012`	`06974703166452`	1	On the market
mLabs® Multi-level CRP Controls	mLabs® Multi-level CRP Controls	`M101-091025`	`06974703166513`	1	On the market
mLabs® Multi-level D-Dimer Controls	mLabs® Multi-level D-Dimer Controls	`M101-091002`	`06974703166414`	1	On the market
mLabs® Multi-level NT-proBNP Controls	mLabs® Multi-level NT-proBNP Controls	`M101-091013`	`06974703166469`	1	On the market
mLabs® Multi-level PCT Controls	mLabs® Multi-level PCT Controls	`M101-091009`	`06974703166445`	1	On the market
mLabs® Multi-level TnI Controls	mLabs® Multi-level TnI Controls	`M101-091007`	`06974703166421`	1	On the market
mLabs® NT-proBNP	mLabs® NT-proBNP	`M101-091005`	`06974703166339`	1	On the market
mLabs® PCT	mLabs® PCT	`M101-091010`	`06974703166346`	1	On the market
mLabs® Troponin I	mLabs® Troponin I	`M101-091003`	`06974703166315`	1	On the market
qLabs® APTT Liquid Control	qLabs® APTT Liquid Control	`QS-9-CL Pro`	`06974703160207`	1	On the market
qLabs® APTT Test Strips	qLabs® APTT Test Strips	`QS-9 Pro`	`06974703160160`	1	On the market
qLabs® Coag Panel 2 Liquid Control	qLabs® Coag Panel 2 Liquid Control	`QS-4-CL Pro`	`06974703160191`	1	On the market
qLabs® Coag Panel 2 Test Strips	qLabs® Coag Panel 2 Test Strips	`QS-4 Pro`	`06974703160177`	1	On the market
qLabs® Coag Panel 4 Test Strips	qLabs® Coag Panel 4 Test Strips	`QS-6 Pro`	`06974703160757`	1	On the market
qLabs® ElectroMeter	qLabs® ElectroMeter	`Q-3`	`06974703168173`	1	On the market
qLabs® FIB Test Strips	qLabs® FIB Test Strips	`QS-18 Pro`	`06974703160269`	1	On the market
qLabs® Multi-level Coag Controls	qLabs® Multi-level Coag Controls	`QS-6-CL Pro`	`06974703160764`	1	On the market
qLabs® PT-INR Liquid Control	qLabs® PT-INR Liquid Control	`QS-1-CL Pro`	`06974703160184`	1	On the market
qLabs® PT-INR Owren (Dry) Test Strips	qLabs® PT-INR Owren (Dry) Test Strips	`QS-2 Pro`	`06974703160795`	1	On the market
qLabs® PT-INR Owren (Dry) Test Strips	qLabs® PT-INR Owren (Dry) Test Strips	`QS-2`	`06974703160788`	1	On the market

Micropoint Biotechnologies Co., Ltd.

About Micropoint

Contact details for Micropoint

Competent authority

Officers and regulatory representatives of Micropoint

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Importers

Export the 29 devices of Micropoint

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About Micropoint

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Officers and regulatory representatives of Micropoint

Statistics for Micropoint

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Device catalog for Micropoint

Device families (Basic UDI-DI) of Micropoint

Market presence of Micropoint

Connected operators

Importers

Export the 29 devices of Micropoint

Related searches

Market presence of Micropoint

Devices by risk class

Certificate health for Micropoint

Statistics for Micropoint

Related documents

Device families (Basic UDI-DI) of Micropoint

Device catalog for Micropoint