HomeChinaChangzhou Huankang Medical Device Co., Ltd.

Changzhou Huankang Medical Device Co., Ltd.

China · Changzhou Jiangsu · www.huankang.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000009030Unified social credit code 91320402251020540Q

This company holds 16 NMPA certificates in China and has registrations in European Union, South Korea, Australia, Russia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
16China registrations
Class II 16
as of 2026-09-04
EUEuropean UnionEUDAMED
216UDI-DI device records
Class I 137Class IIa 79
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union216 raw hits, 0 excluded, 216 confirmed
China16 certificates (Class III 0 / II 16 / I 0), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000009030
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
91320402251020540Q
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Changzhou Jiangsu
Social-insurance enrolees
61
Annual revenue
RMB 50–100M
Website
www.huankang.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systemsWomen’s Health, Neonatology & Pediatric CareObstetrics & gynaecologyIntegrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
1988-07-08
Registered capital
CNY 8,550,000
Paid-in capital
CNY 8,550,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-04-23
Recognitions
Micro and small enterpriseNational High-Tech 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20222180779一次性使用无菌阴道扩张器Class II
CN苏械注准20172181880一次性使用妇检包Class II
CN苏械注准20172081878一次性使用气管插管Class II
CN苏械注准20172021879一次性使用活体取样钳Class II
EU26945934602259suction catheter, cap-cone(control valve)Class IIa
EU16945934602252suction catheter, cap-cone(control valve)Class IIa
EU06945934602255suction catheter, cap cone(control valve)Class IIa
EU26945934604963feeding tubeClass IIa

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