HomeChinaE-LAB BIOLOGICAL SCIENCE & TECHNOLOGY CO., LTD.

E-LAB BIOLOGICAL SCIENCE & TECHNOLOGY CO., LTD.

China · Nanjing Jiangsu · en.bioelab.net
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91320113562870286J

This company holds 99 NMPA certificates in China and has registrations in United States, Brazil, Taiwan — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
99China registrations
Class I 16Class II 83
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
10registered devices
Class II 10
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 Union5,792 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 1 510(k), 0 PMA, 53 excluded
China99 certificates (Class III 0 / II 83 / I 16), as of 2026-09-04
United Kingdom0 confirmed, 15 excluded
Brazil10 confirmed, 19 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: E-LAB BIOLOGICAL SCIENCE & TECHNOLOGY CO., LTD. · E-LAB BIOLOGICAL SCIENCE & TECHNOLOGY CO LTD

Regulatory identity

Unified social credit code
91320113562870286J
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Nanjing Jiangsu
Social-insurance enrolees
259
Annual revenue
RMB 100–500M
Website
en.bioelab.net
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHematology & coagulation

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
2010-11-10
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
Professional technical services
Last approval date
2026-03-03
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle enterpriseInnovative SME

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

11995 · K952118

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20262400238总三碘甲状腺原氨酸测定试剂盒(化学发光免疫分析法)Class II
CN苏械注准20262400215雌二醇测定试剂盒(化学发光免疫分析法)Class II
CN苏械注准20262400206N末端B型利钠肽前体测定试剂盒(化学发光免疫分析法)Class II
CN苏械注准20262400176β-人绒毛膜促性腺激素测定试剂盒(化学发光免疫分析法)Class II
USK952118ELMER1995-08-07
BR80474870078Família de analisadores semi automáticos de bioquímicaClass II
BR80474870109Família de Analisadores Automáticos de Hematologia E-LABClass II
BR80785070213Analisador Semi Automático de Bioquímica VIDA S1000Class II

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