HomeChinaTIANJIN HANACO MEDICAL CO.,LTD

TIANJIN HANACO MEDICAL CO.,LTD

China · 天津 · www.hanacomedical.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000023769Unified social credit code 91120116600551498M

This company holds 36 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
36China registrations
Class I 3Class II 8Class III 23
as of 2026-09-04
EUEuropean UnionEUDAMED
1UDI-DI device records
Class IIa 1
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
13registered devices
Class I 2Class 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
0valid device licences
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 Union1 raw hits, 0 excluded, 1 confirmed
United States2 registration records, 0 510(k), 0 PMA
China36 certificates (Class III 23 / II 8 / I 3), as of 2026-09-04
Brazil13 confirmed, 0 excluded
Manufacturer names merged into this page: TIANJIN HANACO MEDICAL CO.,LTD. · TIANJIN HANACO MEDICAL CO. LTD. · Tianjin Hanaco Xingda Medical Co., Ltd · TIANJIN HANACO XINGDA MEDICAL PRODUCT CO., LTD. · TIANJIN HANACO XINGDA MEDICAL PRODUCT CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000023769
EU authorised representative
MedNet EC-REP C IIb GmbH
Unified social credit code
91120116600551498M
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
477
Annual revenue
RMB 100–500M
Website
www.hanacomedical.com
Product categories
临床检验器械及试剂注输、护理和防护器械输血、透析和体外循环器械

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
1986-08-16
Registered capital
CNY 48,657,779
Paid-in capital
CNY 48,657,779
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-08-26
Recognitions
National High-Tech EnterpriseSRDI SMERecognised enterprise technology centreState Key LaboratoryAbove-designated-size industrial 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.

FDA listed device types

Set, Administration, Intravascular 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263101327一次性使用连续性肾脏替代治疗管路Class III
CN国械注准20243100319一次性使用血液透析管路Class III
CN国械注准20223140217一次性使用精密过滤输液器 带针Class III
CN国械注准20203220899一次性使用防针刺真空采血配套用针Class III
EU06944331090399Disposable Infusion SetsClass IIa
BR80937150008ESCALPE DE SEGURANÇA PARA COLETA DE SANGUE COM ADAPTADOR SOL-CAREClass II
BR80937150006ESCALPE DE SEGURANÇA PARA COLETA DE SANGUE SOL-CAREClass II
BR80937150018ESCALPE PARA INFUSÃO COM DISPOSITIVO DE SEGURANÇA SOL-CAREClass II

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