HomeChinaDongguan Quanding Medical Supplies Co.,Ltd

Dongguan Quanding Medical Supplies Co.,Ltd

China · 东莞 · www.quandingmedical.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000030836Unified social credit code 91441900MA53HJJE9R

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class I 3Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
3UDI-DI device records
Class I 2Class IIb 1
USUnited StatesFDA openFDA
14listed device types
Class I 6Class II 8Class III 0
plus 13 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 5
BRBrazilANVISA
2registered devices
Class II 2
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
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 Union3 raw hits, 0 excluded, 3 confirmed
United States13 registration records, 1 510(k), 0 PMA
China5 certificates (Class III 0 / II 2 / I 3), as of 2026-09-04
United Kingdom5 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: DONGGUAN QUANDING MEDICAL SUPPLIES CO., LTD · DONGGUAN QUANDING MEDICAL SUPPLIES CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000030836
EU authorised representative
Wellkang Ltd
UK responsible person
Wellkang Ltd
Unified social credit code
91441900MA53HJJE9R
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
20
Annual revenue
RMB 50–100M
Website
www.quandingmedical.com
Product categories
手术室及急救中医器械中医版块手术器械医用电子医用诊察和监护器械

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
2019-07-19
Registered capital
CNY 2,000,000
Paid-in capital
CNY 1,980,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2024-08-02
Recognitions
Micro and small 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.

FDA 510(k) clearances by year

12024 · K242204

FDA listed device types

showing 8 of 14
Set, Tubing And Support, Ventilator (W Harness) 1Irrigator, Powered Nasal 1Massager, Therapeutic, Electric 1Unit, Chilling 1Bandage, Elastic 1Unit, Heating, Powered 1Electrosurgical, Cutting & Coagulation & Accessories 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252080176一次性使用除颤电极Class II
CN粤械注准20232011374一次性使用中性电极Class II
CN粤莞械备20200205号理疗用体表电极Class I
CN粤莞械备20200205理疗用体表电极Class I
EU06975585870369Adhesive Electrodes (TENS Electrodes)Class I
EU06975585870390ECG ElectrodeClass I
EU06975585871007Defibrillation Electrode PadsClass IIb
UK35035Disposable ECG ElectrodesClass I
UK65319Adhesive Electrodes (TENS Electrodes)Class I
UK58494Patient Return ElectrodeClass I
USK242204Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)2024-09-25
BR10360319028Eletrodos para NeuroestimulaçãoClass II
BR83348059001ELETRODO ELETROTERAPIA (TENS/EMS/FES) - AKMEDClass II

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