HomeChinaDragon Heart Medical Devices Co.,ltd.

Dragon Heart Medical Devices Co.,ltd.

China · 江门 · www.dragonheart-ltd.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000011438Unified social credit code 91440783617756502J

This company holds 28 NMPA certificates in China and has registrations in European Union, United States, Saudi Arabia, Canada — 4 overseas markets. EU UDI-DI records ≥18, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
28China registrations
Class I 4Class II 10Class III 14
as of 2026-09-04
EUEuropean UnionEUDAMED
≥18UDI-DI device records
Class I 18
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
50listed device types
Class I 41Class II 8Class III 0unclassified 1
plus 53 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
42registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
TWTaiwanTFDA
pendingnot queried
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 Union2,300 raw hits, 282 excluded, 18 confirmed. Large result set — only the first 300 verified
United States53 registration records, 3 510(k), 0 PMA, 9 excluded
China28 certificates (Class III 14 / II 10 / I 4), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil0 confirmed, 5 excluded
Saudi Arabia42 confirmed, 3 excluded
Canada3 confirmed, 1 excluded
Manufacturer names merged into this page: Dragon Medical Co.,Ltd · DRAGON HEART MEDICAL, INC. · DRAGON HEART MEDICAL DEVICES CO., LTD. · DRAGON HEART MEDICAL DEVICES CO. LTD. · DRAGON MEDICAL CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000011438
EU authorised representative
MedPath GmbH
Unified social credit code
91440783617756502J
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
171
Annual revenue
RMB 50–100M
Website
www.dragonheart-ltd.com
Product categories
手术器械临床检验器械及试剂注输、护理和防护器械妇产科、辅助生殖和避孕器械

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
1996-11-08
Registered capital
CNY 90,180,000
Paid-in capital
CNY 90,180,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-04-10
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI 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

12004 · K042547
12005 · K043235
12010 · K101368

FDA listed device types

showing 8 of 50
Stretcher, Hand-Carried 1Toothbrush, Powered 1Scissors, Medical, Disposable 1Table, Operating-Room, Manual 1Regulator, Pressure, Gas Cylinder 1First Aid Kit Without Drug 1Lift, Patient, Non-Ac-Powered 1Airway, Nasopharyngeal 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20193141947一次性使用精密输液器带针Class III
CN国械注准20193140498一次性使用精密过滤输液器 带针Class III
CN国械注准20193021852α-氰基丙烯酸正丁酯医用粘合剂Class III
CN国械注准20173140816一次性使用输液器 带针Class III
EU06942455708923Shower chairClass I
EU06942455708916Electric WheelchairClass I
EU06942455708909Electric WheelchairClass I
EU06942455708893Electric WheelchairClass I
USK101368D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES2010-11-18
USK043235DRAGON HEART I.V. SET2005-03-08
USK042547DRAGON HEART PISTON SYRINGE2004-12-01
SAME0000005075SFDAA00012STRETCHER FOLDING
SAME0000002303SFDAA00006EMERGENCY TROLLEY INSTRUCTIONS FOR USE
CA84629DISPOSABLE SINGLE USE SYRINGESClass II
CA84758IV ADMINISTRATION SETSClass II
CA94509DENTAL IRRIGATION TIPSClass II

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