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JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000012807Unified social credit code 91320623MA1MKF9Q90

This company holds 44 NMPA certificates in China and has registrations in European Union, United States, Australia, Israel — 4 overseas markets. EU UDI-DI records ≥13, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

44China registrations

Class I 23Class II 7Class III 14

as of 2026-09-04

EUEuropean UnionEUDAMED

≥13UDI-DI device records

IVD A 10IVD B 3

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

11listed device types

Class I 9Class II 2Class III 0

plus 11 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union1,151 raw hits, 287 excluded, 13 confirmed. Large result set — only the first 300 verified

United States11 registration records, 1 510(k), 0 PMA, 2 excluded

China44 certificates (Class III 14 / II 7 / I 23), as of 2026-09-04

United Kingdom0 confirmed, 6 excluded

Manufacturer names merged into this page: JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000012807
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code: 91320623MA1MKF9Q90
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2016-05-06
Registered capital: CNY 20,000,000
Paid-in capital: CNY 20,000,000
Legal form: Limited liability company
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-05-13
Recognitions: Micro and small enterpriseTechnology-based SMEPrivate technology enterprise

Business registration data from Tianyancha, as of 2026-09-02. 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.

FDA 510(k) clearances by year

12023 · K230741

FDA listed device types

showing 8 of 11

Kit, Test, Pregnancy, Hcg, Over The Counter 1Instrumentation For Clinical Multiplex Test Systems 1Test, Luteinizing Hormone (Lh), Over The Counter 1Immunoassay, Insulin-Like Growth Factor Binding Protein-1 1Antigens, Ha (Including Ha Control), Adenovirus 1-33 1Clinical Sample Concentrator 1Container, Specimen, Non-Sterile 1Fluorometer, For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263401320	金黄色葡萄球菌和耐甲氧西林金黄色葡萄球菌核酸检测试剂盒（荧光PCR法）	Class III
CN	国械注准20253401152	A群轮状病毒、腺病毒抗原检测试剂盒（胶体金法）	Class III
CN	国械注准20253401119	甲型流感病毒/乙型流感病毒核酸检测试剂盒（荧光PCR法）	Class III
CN	国械注准20253401045	猴痘病毒核酸检测试剂盒（荧光PCR法）	Class III
EU	06974849369885	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	IVD A
EU	06974849369878	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	IVD A
EU	06974849369861	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.	IVD A
EU	06974849369854	—	IVD A
US	K230741	Macro & Micro-Test HCG Pregnancy Test Midstream	2023-10-13

JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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