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Nanjing Synthgene Medical Technology Co., Ltd.

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000023810Unified social credit code 91320114MA1X09DE0U

This company has registrations in European Union, United States, United Kingdom, Singapore, Australia, Hong Kong — 6 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

85UDI-DI device records

IVD A 1IVD general 83ivd-devices-self-testing 1

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

25registered device records

IVD general 24IVD Devices for Self-Testing 1

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 3 2

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union150 raw hits, 65 excluded, 85 confirmed

United States0 registration records, 1 510(k), 0 PMA

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom25 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: CN-MF-000023810
EU authorised representative: MedPath GmbH
UK responsible person: NPZ technology Ltd
Unified social credit code: 91320114MA1X09DE0U
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2018-08-02
Registered capital: CNY 5,000,000
Paid-in capital: CNY 3,528,300
Legal form: Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification: Research and experimental development
Last approval date: 2024-08-26
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-CNMF000023810CFCR056MB	Chikungunya Fever IgG/IgM Antibody Test Kit (Colloidal Gold Method)	IVD general
EU	D-CNMF000023810LDKCW024K9	Lactose Detection Kit (Enzyme Cascade Method)	IVD general
EU	06974473306935	SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method)	IVD general
EU	06974473303712	HC-10 Portable Colloidal Gold Immunoassay Analyzer	IVD A
UK	55489	AMP Rapid Test Kit (Colloidal gold method)	IVD general
UK	52995	CK-MB Rapid Test Kit (Colloidal gold method)	IVD general
UK	47343	D-Dimer Rapid Test Kit (Colloidal gold method)	IVD general
US	K242135	Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream	2025-01-31

Nanjing Synthgene Medical Technology Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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