HomeChinaYERCON DIAGNOSTIC CO.,LTD

YERCON DIAGNOSTIC CO.,LTD

China · 长春 · www.yerconlab.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000028380Unified social credit code 9122010167731540XY

This company holds 3 NMPA certificates in China and has registrations in European Union, United Kingdom, Brazil, Australia, Israel — 5 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
3China registrations
Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
IVD A 12IVD general 189ivd-devices-self-testing 99
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
IVD general 1IVD Devices for Self-Testing 1
BRBrazilANVISA
5registered devices
Class II 5
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
2active ARTG entries
IVD Class 2 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union356 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
China3 certificates (Class III 0 / II 3 / I 0), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: YERCON DIAGNOSTIC CO., LTD. · YERCON DIAGNOSTIC CO. LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000028380
EU authorised representative
CMC Medical Devices & Drugs SL
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
9122010167731540XY
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
31
Annual revenue
RMB 10–30M
Website
www.yerconlab.com

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2008-08-21
Registered capital
CNY 2,000,000
Paid-in capital
CNY 2,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-12-31
Recognitions
Micro and small 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN吉械注准20222400852尿液分析试纸Class II
CN吉械注准20222400818尿液分析试纸条Class II
CN吉械注准20182400025尿液分析试纸条Class II
EU06971007258982IVD A
EU06971007258975IVD A
EU06971007258968IVD A
EU06971007258951IVD A
UK54514Reagent strips for UrinalysisIVD general
UK65931Reagent strips for UrinalysisIVD Devices for Self-Testing
BR82195300035Tiras reagentes para urinálise URS-11SClass II
BR82195300036Tiras reagentes para urinálise URS-10SClass II
BR82195300037Tiras reagentes para urinálise URS-14SClass II

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