MD Atlas update: Jun 11, 2026

Synthgene (Yixing) Health Technology Co., Ltd.

CN-MF-000054349

Active65 devices

Address: 2nd Floor,Area B and 4A02,4th Floor, Area A, Building 7,Yiyao Health Science and Technology Park, No.63 Science and Technology Avenue,Gaocheng Town, 214200 Yixing City
Role: Manufacturer
Date of registration: May 12, 2026
Country: China

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Synthgene (Yixing) Health Technology Co., Ltd. is a medical device manufacturer registered in EUDAMED. The company has 65 devices on the EU market in China. Headquartered in Yixing City, China. Explore the regulatory profile, devices and certificates on MD Atlas.

Role
Country
Date of registration
Address

MD Atlas update: Jun 11, 2026

Synthgene (Yixing) Health Technology Co., Ltd.

CN-MF-000054349

Active65 devices

Address: 2nd Floor,Area B and 4A02,4th Floor, Area A, Building 7,Yiyao Health Science and Technology Park, No.63 Science and Technology Avenue,Gaocheng Town, 214200 Yixing City
Role: Manufacturer
Date of registration: May 12, 2026
Country: China

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About Synthgene (Yixing) Health Technology Co., Ltd.

SRN: CN-MF-000054349
Role: Manufacturer
Country: China
Organization name: Synthgene (Yixing) Health Technology Co., Ltd.
EU VAT number: Not applicable
Trade register: 91320191MAC6N5978D
Date of registration: May 12, 2026

Contact details for Synthgene (Yixing) Health Technology Co., Ltd.

Email: sales@syngenebio.com
Address: 2ND FLOOR,AREA B AND 4A02,4TH FLOOR, AREA A, BUILDING 7,YIYAO HEALTH SCIENCE AND TECHNOLOGY PARK, NO.63 SCIENCE AND TECHNOLOGY AVENUE,GAOCHENG TOWN 214200 YIXING CITY CHINA

Competent authority

Name: DE/CA304 - Marktüberwachung Medizinprodukte Bayern
SRN: DE-CA-047
Phone: +49 941 5680-0
Email: MP.BY@reg-opf.bayern.de

Officers and regulatory representatives of Synthgene (Yixing) Health Technology Co., Ltd.

ZHENG Jing
Hidden

Certificate health for Synthgene (Yixing) Health Technology Co., Ltd.

No certificates registered for this manufacturer.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
KET Rapid Test Kit (Colloidal gold method)	`DP004`	`D-CNMF000054349DP004G8`	1	On the market
6-MAM Rapid Test Kit (Colloidal gold method)	`DP018`	`D-CNMF000054349DP018GK`	1	On the market
ALC Rapid Test Kit (Colloidal gold method)	`DP019`	`D-CNMF000054349DP019GM`	1	On the market
AMP Rapid Test Kit(Colloidal gold method)	`DP001`	`D-CNMF000054349DP001G2`	1	On the market
APAP Rapid Test Kit (Colloidal gold method)	`DP028`	`D-CNMF000054349DP028GN`	1	On the market
Bacterial vaginosis Rapid Test Kit (Colloidal gold method)	`CR028`	`D-CNMF000054349CR028GR`	1	On the market
BAR Rapid Test Kit(Colloidal gold method)	`DP006`	`D-CNMF000054349DP006GC`	1	On the market
BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)	`DP010`	`D-CNMF000054349DP010G3`	1	On the market
BZO Rapid Test Kit(Colloidal gold method)	`DP007`	`D-CNMF000054349DP007GE`	1	On the market
Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)	`CR025`	`D-CNMF000054349CR025GK`	1	On the market
COC Rapid Test Kit(Colloidal gold method)	`DP008`	`D-CNMF000054349DP008GG`	1	On the market
COT Rapid Test Kit (Colloidal gold method)	`DP015`	`D-CNMF000054349DP015GD`	1	On the market
COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method)	`RQ007`	`D-CNMF000054349RQ007MF`	1	On the market
COVID-19/Influenza(A+B)/RSV Antigen Combo Rapid Test Kit(Colloidal gold method)	`RQ009`	`D-CNMF000054349RQ009MK`	1	On the market
Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)	`CR010`	`D-CNMF000054349CR010G6`	1	On the market
Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)	`CR011`	`D-CNMF000054349CR011G8`	1	On the market
Dengue NS1 Rapid Test Kit (Colloidal gold method)	`CR022`	`D-CNMF000054349CR022GD`	1	On the market
DP013	`DP013`	`D-CNMF000054349DP013G9`	1	On the market
EDDP Rapid Test Kit (Colloidal gold method)	`DP025`	`D-CNMF000054349DP025GG`	1	On the market
FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)	`CR006`	`D-CNMF000054349CR006GF`	1	On the market
FOB Rapid Test Kit	`CR009`	`D-CNMF000054349CR009GM`	1	On the market
FSH Rapid Test Kit (Colloidal gold method)	`YS003`	`D-CNMF000054349YS003Q2`	1	On the market
H. Pylori Antibody Rapid Test Kit(Colloidal gold method)	`CR008`	`D-CNMF000054349CR008GK`	1	On the market
H. Pylori Antigen Rapid Test Kit	`CR007`	`D-CNMF000054349CR007GH`	1	On the market
HCG Rapid Test Kit	`YS002`	`D-CNMF000054349YS002PY`	1	On the market

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
KET Rapid Test Kit (Colloidal gold method)	`DP004`	`D-CNMF000054349DP004G8`	1	On the market
6-MAM Rapid Test Kit (Colloidal gold method)	`DP018`	`D-CNMF000054349DP018GK`	1	On the market
ALC Rapid Test Kit (Colloidal gold method)	`DP019`	`D-CNMF000054349DP019GM`	1	On the market
AMP Rapid Test Kit(Colloidal gold method)	`DP001`	`D-CNMF000054349DP001G2`	1	On the market
APAP Rapid Test Kit (Colloidal gold method)	`DP028`	`D-CNMF000054349DP028GN`	1	On the market
Bacterial vaginosis Rapid Test Kit (Colloidal gold method)	`CR028`	`D-CNMF000054349CR028GR`	1	On the market
BAR Rapid Test Kit(Colloidal gold method)	`DP006`	`D-CNMF000054349DP006GC`	1	On the market
BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)	`DP010`	`D-CNMF000054349DP010G3`	1	On the market
BZO Rapid Test Kit(Colloidal gold method)	`DP007`	`D-CNMF000054349DP007GE`	1	On the market
Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)	`CR025`	`D-CNMF000054349CR025GK`	1	On the market
COC Rapid Test Kit(Colloidal gold method)	`DP008`	`D-CNMF000054349DP008GG`	1	On the market
COT Rapid Test Kit (Colloidal gold method)	`DP015`	`D-CNMF000054349DP015GD`	1	On the market
COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method)	`RQ007`	`D-CNMF000054349RQ007MF`	1	On the market
COVID-19/Influenza(A+B)/RSV Antigen Combo Rapid Test Kit(Colloidal gold method)	`RQ009`	`D-CNMF000054349RQ009MK`	1	On the market
Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)	`CR010`	`D-CNMF000054349CR010G6`	1	On the market
Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)	`CR011`	`D-CNMF000054349CR011G8`	1	On the market
Dengue NS1 Rapid Test Kit (Colloidal gold method)	`CR022`	`D-CNMF000054349CR022GD`	1	On the market
DP013	`DP013`	`D-CNMF000054349DP013G9`	1	On the market
EDDP Rapid Test Kit (Colloidal gold method)	`DP025`	`D-CNMF000054349DP025GG`	1	On the market
FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)	`CR006`	`D-CNMF000054349CR006GF`	1	On the market
FOB Rapid Test Kit	`CR009`	`D-CNMF000054349CR009GM`	1	On the market
FSH Rapid Test Kit (Colloidal gold method)	`YS003`	`D-CNMF000054349YS003Q2`	1	On the market
H. Pylori Antibody Rapid Test Kit(Colloidal gold method)	`CR008`	`D-CNMF000054349CR008GK`	1	On the market
H. Pylori Antigen Rapid Test Kit	`CR007`	`D-CNMF000054349CR007GH`	1	On the market
HCG Rapid Test Kit	`YS002`	`D-CNMF000054349YS002PY`	1	On the market

Synthgene (Yixing) Health Technology Co., Ltd.

Synthgene (Yixing) Health Technology Co., Ltd.

About Synthgene (Yixing) Health Technology Co., Ltd.

Contact details for Synthgene (Yixing) Health Technology Co., Ltd.

Competent authority

Officers and regulatory representatives of Synthgene (Yixing) Health Technology Co., Ltd.

Certificate health for Synthgene (Yixing) Health Technology Co., Ltd.

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About Synthgene (Yixing) Health Technology Co., Ltd.

Contact details for Synthgene (Yixing) Health Technology Co., Ltd.

Competent authority

Officers and regulatory representatives of Synthgene (Yixing) Health Technology Co., Ltd.

Statistics for Synthgene (Yixing) Health Technology Co., Ltd.

Certificate health for Synthgene (Yixing) Health Technology Co., Ltd.

Related documents

Devices by risk class

Device catalog for Synthgene (Yixing) Health Technology Co., Ltd.

Device families (Basic UDI-DI) of Synthgene (Yixing) Health Technology Co., Ltd.

Market presence of Synthgene (Yixing) Health Technology Co., Ltd.

Related searches

Statistics for Synthgene (Yixing) Health Technology Co., Ltd.

Device catalog for Synthgene (Yixing) Health Technology Co., Ltd.

Device families (Basic UDI-DI) of Synthgene (Yixing) Health Technology Co., Ltd.

Market presence of Synthgene (Yixing) Health Technology Co., Ltd.