HomeChinaHEBEI XINLE SCI&TECH CO., LTD

HEBEI XINLE SCI&TECH CO., LTD

China · Shijiazhuang City Hebei Province · www.xinlemedical.com
✓ Record-verifiedregistrations found in 6 marketsUnified social credit code 91130100779181932M

This company holds 28 NMPA certificates in China and has registrations in United States, Brazil, Taiwan, Israel, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
28China registrations
Class I 10Class II 15Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
17registered devices
Class I 6Class II 11
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
17valid device licences
Class I 2Class II 15
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 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 Union39,523 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States1 registration records, 1 510(k), 0 PMA, 2 excluded
China28 certificates (Class III 3 / II 15 / I 10), as of 2026-09-04
United Kingdom0 confirmed, 230 excluded
Brazil17 confirmed, 0 excluded
Manufacturer names merged into this page: HEBEI XINLE SCI&TECH CO.,LTD · HEBEI XINLE SCI & TECH CO., LTD. · HEBEI XINLE SCI & TECH CO.,LTD.

Regulatory identity

Unified social credit code
91130100779181932M
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shijiazhuang City Hebei Province
Social-insurance enrolees
604
Annual revenue
RMB 100–500M
Website
www.xinlemedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsLaboratory automation & robotics

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
2005-09-07
Registered capital
CNY 62,000,000
Paid-in capital
CNY 61,999,900
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-08-24
Recognitions
National High-Tech EnterpriseTechnology-based SMETechnology Innovation Demonstration EnterpriseAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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

12022 · K221839

FDA listed device types

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253221089一次性使用防针刺静脉采血针Class III
CN国械注准20163221681一次性使用静脉采血针Class III
CN国械注准20163220454一次性使用静脉采血针Class III
CN冀械注准20262220108一次性使用血管紧张素检测采血管Class II
USK221839Lancet2022-09-19
BR81628880018Família Microtubo para coleta de sangueClass I
BR80298970124TUBOS PARA COLETA DE SANGUE A VÁCUO PARA VHS MAX PLÁSTICOClass I
BR80298970125TUBOS PARA COLETA DE SANGUE A VÁCUO PARA VHS MAX VIDROClass I

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