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Dragon Medical Co., Ltd

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000011438Unified social credit code 91320582MA1MHL9M6H

This company holds 45 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 9 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

45China registrations

Class I 41Class II 4

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 30Class IIa 270

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

54listed device types

Class I 42Class II 11Class III 0unclassified 1

plus 61 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 1Class IIa 4

BRBrazilANVISA

24registered devices

Class I 2Class II 22

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

4active device licences

Class II 4

5 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

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, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States61 registration records, 4 510(k), 0 PMA, 6 excluded

China45 certificates (Class III 0 / II 4 / I 41), as of 2026-09-04

United Kingdom5 confirmed, 0 excluded

Brazil24 confirmed, 1 excluded

Saudi Arabia42 confirmed, 3 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: Dragon Medical Co.,Ltd · DRAGON HEART MEDICAL, INC. · WUJIANG CITY CLOUD & DRAGON MEDICAL DEVICE CO., LTD · DRAGON HEART MEDICAL DEVICES CO., LTD. · DRAGON HEART MEDICAL DEVICES CO. LTD. · WUJIANG CITY CLOUD & DRAGON MEDICAL DEVICE CO. LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000011438
EU authorised representative: MedPath GmbH
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91320582MA1MHL9M6H
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2016-04-07
Registered capital: CNY 10,000,000
Paid-in capital: CNY 880,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2025-04-27
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseGazelle 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 510(k) clearances by year

12004 · K042547

12005 · K043235

12010 · K101368

12017 · K162283

FDA listed device types

showing 8 of 54

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)

Market	Identifier	Name	Class / date
CN	苏械注准20262191153	电动轮椅车	Class II
CN	苏械注准20262150941	电动担架车	Class II
CN	苏械注准20222191961	电动轮椅车	Class II
CN	苏械注准20222152095	电动担架车	Class II
EU	06942455708923	Shower chair	Class I
EU	06931833106581	—	Class IIa
EU	06931833105157	—	Class IIa
EU	06931833107182	—	Class IIa
UK	34175	Disposable Acupuncture Needles	Class IIa
UK	34175	Disposable Intradermal Embedding Needles	Class IIa
UK	47573	Disposable Dermal Needles	Class IIa
US	K162283	DCM Kyphoplasty System	2017-02-06
US	K101368	D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES	2010-11-18
US	K043235	DRAGON HEART I.V. SET	2005-03-08
BR	82807480013	Expandable Retractor	Class I
BR	82807489001	Spinal Endoscope	Class II
BR	82151269014	Kit Vertebroexpansiva Dragon Crown	Class II
SA	ME0000005075SFDAA00012	STRETCHER FOLDING	—
SA	ME0000002303SFDAA00006	EMERGENCY TROLLEY INSTRUCTIONS FOR USE	—
CA	84629	DISPOSABLE SINGLE USE SYRINGES	Class II
CA	84758	IV ADMINISTRATION SETS	Class II
CA	94509	DENTAL IRRIGATION TIPS	Class II

Dragon Medical Co., Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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