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Core Technology Co.,Ltd.

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000033296Unified social credit code 91110114785541383H

This company holds 62 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Hong Kong, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥29, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

62China registrations

Class II 17Class III 45

as of 2026-09-04

EUEuropean UnionEUDAMED

≥29UDI-DI device records

Class III 1ivd-devices-self-testing 28

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

USUnited StatesFDA openFDA

14listed device types

Class I 3Class II 9Class III 0unclassified 2

plus 8 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

9registered device records

IVD general 1IVD Annex II List A 3IVD Devices for Self-Testing 5

BRBrazilANVISA

12registered devices

Class II 12

14 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 1Class 2b 1Class 3 4

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 Union1,522 raw hits, 271 excluded, 29 confirmed. Large result set — only the first 300 verified

United States8 registration records, 0 510(k), 0 PMA, 31 excluded

China62 certificates (Class III 45 / II 17 / I 0), as of 2026-09-04

United Kingdom9 confirmed, 15 excluded

Brazil12 confirmed, 3 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: CORE TECHNOLOGY CO., LTD. · BEIJING CORE TECHNOLOGY CO., LTD. · CORE TECHONOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000033296
EU authorised representative: Wellkang Ltd
UK responsible person: Wellkang Ltd
Unified social credit code: 91110114785541383H
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2006-02-08
Registered capital: CNY 10,000,000
Paid-in capital: CNY 10,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-05-26
Recognitions: National High-Tech EnterpriseTechnology-based SMEGazelle enterpriseRecognised enterprise technology centre

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 listed device types

showing 8 of 14

Covid-19 Multi-Analyte Antigen Device 1Coronavirus Antigen Detection Test System. 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Test, Luteinizing Hormone (Lh), Over The Counter 1Test System, Nicotine, Cotinine, Metabolites 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Enzyme Immunoassay, Opiates 1Test, Opiates, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20253401576	多项毒品唾液联合检测试剂盒（胶体金法）	Class III
CN	国械注准20253401514	多项毒品唾液联合检测试剂盒（胶体金法）	Class III
CN	国械注准20253401408	多项毒品联合检测试剂盒（胶体金法）	Class III
CN	国械注准20253401147	新型冠状病毒（2019-nCoV）抗原检测试剂盒（胶体金法）	Class III
EU	16974309711275	—	Class III
EU	06942468139189	vitalio Ovulation test	ivd-devices-self-testing
EU	06942468139196	vitalio Pregnancy test	ivd-devices-self-testing
EU	06942468139202	vitalio Early Pregnancy test	ivd-devices-self-testing
UK	65665	Faecal occult blood IVD, kit, rapid ICT, self-testing	IVD Devices for Self-Testing
UK	65841	Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing	IVD Devices for Self-Testing
UK	48322	Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical	IVD Annex II List A
BR	10208250057	ANDALAN DIAGNÓSTICOS - TESTE DE OVULAÇÃO	Class II
BR	10208250058	ANDALAN DIAGNÓSTICOS - TESTE DE GRAVIDEZ	Class II
BR	80638720055	Teste de Gravidez	Class II