HomeChinaEQUINOX BIOTECH CO., LTD

EQUINOX BIOTECH CO., LTD

China · 汕头 · www.runbio-bio.com
✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000018901Unified social credit code 91440500741727768H

This company holds 29 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 10 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
29China registrations
Class II 16Class III 13
as of 2026-09-04
EUEuropean UnionEUDAMED
17UDI-DI device records
IVD general 13ivd-devices-self-testing 4
USUnited StatesFDA openFDA
5listed device types
Class I 3Class II 2Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
6registered device records
IVD general 2IVD Devices for Self-Testing 4
BRBrazilANVISA
3registered devices
Class II 3
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
10 including historic records
TWTaiwanTFDA
5valid device licences
Class I 5
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 2 1
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 Union17 raw hits, 0 excluded, 17 confirmed
United States6 registration records, 0 510(k), 0 PMA
China29 certificates (Class III 13 / II 16 / I 0), as of 2026-09-04
United Kingdom6 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: Equinox Biotech Co., Ltd. · EQUINOX BIOTECH CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000018901
EU authorised representative
MedNet EC-REP GmbH
UK responsible person
Medimap Ltd
Unified social credit code
91440500741727768H
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
510
Annual revenue
RMB 100–500M
Website
www.runbio-bio.com
Product categories
临床检验器械及试剂

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
2001-04-30
Registered capital
CNY 50,000,000
Paid-in capital
CNY 49,753,153
Legal form
Joint-stock limited company (foreign-invested)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-03-17
Recognitions
National High-Tech EnterpriseSRDI SMERecognised 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

Kit, Test, Pregnancy, Hcg, Over The Counter 1Visual, Pregnancy Hcg, Prescription Use 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Urine Collection Kit (Excludes Hiv Testing) 1Test, Luteinizing Hormone (Lh), Over The Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253401407幽门螺杆菌抗原检测试剂盒(胶体金法)Class III
CN国械注准20193401788乙型肝炎病毒表面抗体检测试剂盒(胶体金法)Class III
CN国械注准20193401786乙型肝炎病毒表面抗原、表面抗体、e抗原、e抗体、核心抗体检测试剂盒(胶体金法)Class III
CN国械注准20193401785乙型肝炎病毒表面抗原检测试剂盒(胶体金法)Class III
EUD-RH-HCGE4DAVID, Family Care Med+, Z1 Pharma , KTX7ivd-devices-self-testing
EUD-RH-LHZADAVID, Family Care Med+, Z1 Pharmaivd-devices-self-testing
EUD-RH-SP10XWDAVID, easy@Homeivd-devices-self-testing
EUD-RH-FSHFCDAVIDivd-devices-self-testing
UK65841DAVID One Step FSH Urine Tests for Self-testingIVD Devices for Self-Testing
UK54255DAVID One Step Ovulation Urine Tests for Self-testingIVD Devices for Self-Testing
UK60471DAVID Urine Microalbumin (MAU) TestIVD general
BR82505530004Proov Reserve - Teste de FSHClass II
BR82505530002CheckClass II
BR82505530003PredictClass II

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