MD Atlas update: Aug 15, 2026

Yaneng BIOscience (Shenzhen) Co., Ltd.

CN-MF-000013666

Active153 devices

Address: SDGI Optical Network Building, Shutianpu Community, Matian Street, Guangming District, Shenzhen, Guangdong Province, PEOPLE'S REPUBLIC OF, Room 401 518106 Shenzhen, Guangdong Province
Role: Manufacturer
Date of registration: Sep 27, 2021
Country: China

Yaneng BIOscience (Shenzhen) Co., Ltd. is a medical device manufacturer registered in EUDAMED. The company has 153 devices on the EU market in China. Headquartered in Shenzhen, Guangdong Province, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Yaneng

: CN-MF-000013666
Role: Manufacturer
Country: China
Organization name: Yaneng BIOscience (Shenzhen) Co., Ltd.
EU VAT number: Not applicable
Trade register: 91440300728572933L
Date of registration: Sep 27, 2021

Contact details for Yaneng

Email: yanengce@yanengbio.com
Website: www.yanengbio.com
Address: ROOM 401, SDGI OPTICAL NETWORK BUILDING, SHUTIANPU COMMUNITY, MATIAN STREET, GUANGMING DISTRICT, SHENZHEN, GUANGDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA 518106 SHENZHEN, GUANGDONG PROVINCE CHINA

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Export the 153 devices of Yaneng

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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 Yaneng

LUO Li
Ensuring that: (a) the conformity of the devices is checked in the full lifecycle, in accordance with the QMS. (b) the technical documentation and the EU DoC are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied; (d) the reporting obligations are fulfilled; (e) issued the regulatory statement in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other applicable situation.
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Connected operators

Importers

1 EU importer places this manufacturer's devices

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
Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)	Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)	`212901`	`06955931302881`	1	On the market
Alpha Thalassemia Genotyping Kit (gap-PCR)	Alpha Thalassemia Genotyping Kit (gap-PCR)	`210425`	`06955931304878`	1	On the market
Automatic Hybridization System	Automatic Hybridization System	`230401`	`06955931302430`	1	On the market
Automatic Integrated Nucleic Acid Analyzer	Automatic Integrated Nucleic Acid Analyzer	`2309HD`	`06955931304250`	1	On the market
Automatic Nucleic Acid Extraction System	Automatic Nucleic Acid Extraction System	`230501`	`06955931303116`	1	On the market
Automatic Nucleic Acid Sample Processing System	Automatic Nucleic Acid Sample Processing System	`2310PW`	`06955931304267`	1	On the market
Automatic Reagent Pipetting System	Automatic Reagent Pipetting System	`230601`	`06955931303123`	1	On the market
Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)	Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)	`213001`	`06955931305141`	1	On the market
Beta Thalassemia Genotyping kit (Multicolor Melting Curve Analysis)	Beta Thalassemia Genotyping kit (Multicolor Melting Curve Analysis)	`213001`	`06955931305158`	1	On the market
Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	`211201`	`06955931304915`	1	On the market
Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	`211201`	`06955931304939`	1	On the market
Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	`211201`	`06955931304922`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304526`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304595`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304588`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304496`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304540`	1	On the market
Buffer Solution	Buffer Solution	`240301`	`06955931304632`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304519`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304571`	1	On the market
Buffer Solution	Buffer Solution	`240301`	`06955931304649`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304502`	1	On the market
Buffer Solution	Buffer Solution	`240301`	`06955931304656`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304489`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304564`	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
Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)	Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)	`212901`	`06955931302881`	1	On the market
Alpha Thalassemia Genotyping Kit (gap-PCR)	Alpha Thalassemia Genotyping Kit (gap-PCR)	`210425`	`06955931304878`	1	On the market
Automatic Hybridization System	Automatic Hybridization System	`230401`	`06955931302430`	1	On the market
Automatic Integrated Nucleic Acid Analyzer	Automatic Integrated Nucleic Acid Analyzer	`2309HD`	`06955931304250`	1	On the market
Automatic Nucleic Acid Extraction System	Automatic Nucleic Acid Extraction System	`230501`	`06955931303116`	1	On the market
Automatic Nucleic Acid Sample Processing System	Automatic Nucleic Acid Sample Processing System	`2310PW`	`06955931304267`	1	On the market
Automatic Reagent Pipetting System	Automatic Reagent Pipetting System	`230601`	`06955931303123`	1	On the market
Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)	Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)	`213001`	`06955931305141`	1	On the market
Beta Thalassemia Genotyping kit (Multicolor Melting Curve Analysis)	Beta Thalassemia Genotyping kit (Multicolor Melting Curve Analysis)	`213001`	`06955931305158`	1	On the market
Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	`211201`	`06955931304915`	1	On the market
Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	`211201`	`06955931304939`	1	On the market
Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)	`211201`	`06955931304922`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304526`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304595`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304588`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304496`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304540`	1	On the market
Buffer Solution	Buffer Solution	`240301`	`06955931304632`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304519`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304571`	1	On the market
Buffer Solution	Buffer Solution	`240301`	`06955931304649`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304502`	1	On the market
Buffer Solution	Buffer Solution	`240301`	`06955931304656`	1	On the market
Buffer Solution	Buffer Solution	`2401SC`	`06955931304489`	1	On the market
Buffer Solution	Buffer Solution	`240201`	`06955931304564`	1	On the market

Yaneng BIOscience (Shenzhen) Co., Ltd.

About Yaneng

Contact details for Yaneng

Export the 153 devices of Yaneng

Competent authority

Officers and regulatory representatives of Yaneng

Connected operators

Importers

Related searches

About Yaneng

Contact details for Yaneng

Export the 153 devices of Yaneng

Competent authority

Officers and regulatory representatives of Yaneng

Statistics for Yaneng

Certificate health for Yaneng

Devices by risk class

Market presence of Yaneng

Device catalog for Yaneng

Device families (Basic UDI-DI) of Yaneng

Connected operators

Importers

Related searches

Certificate health for Yaneng

Statistics for Yaneng

Market presence of Yaneng

Devices by risk class

Device catalog for Yaneng

Device families (Basic UDI-DI) of Yaneng