HomeChinaShenzhen Xilaiheng Medical Electronics Co., Ltd

Shenzhen Xilaiheng Medical Electronics Co., Ltd

China · 深圳 · www.xilaiheng.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000047090Unified social credit code 91440300708400894W

This company holds 85 NMPA certificates in China and has registrations in European Union, Brazil, Russia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
85China registrations
Class I 21Class II 64
as of 2026-09-04
EUEuropean UnionEUDAMED
22UDI-DI device records
IVD A 18IVD general 4
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
22registered devices
Class I 4Class II 18
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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union22 raw hits, 0 excluded, 22 confirmed
China85 certificates (Class III 0 / II 64 / I 21), as of 2026-09-04
Brazil22 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN XILAIHENG MEDICAL ELECTRONICS CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000047090
EU authorised representative
MedNet EC-REP GmbH
Unified social credit code
91440300708400894W
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
195
Annual revenue
RMB 50–100M
Website
www.xilaiheng.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
1998-04-24
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-05-27
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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粤械注准20262400712总二氧化碳(TCO2)测定试剂盒(量压法)Class II
CN粤械注准20262400693电解质多项校准品Class II
CN粤械注准20262220727电解质分析仪Class II
CN粤械注准20262220239全自动三分类血细胞分析仪Class II
EU06975200383465IVD A
EU06975200383007IVD A
EU06975200381553IVD A
EU06975200380938IVD A
BR80298970090LEITOR AUTOMÁTICO DE VHS MAXClass II
BR80298970091ANALISADOR DE PROTEÍNAS MAX PROT 700Class II
BR81452980015Analisador de Eletrólitos (ISE) H900Class II

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