HomeChinaHUIZHOU KAIYI TECHNOLOGY CO.,LTD

HUIZHOU KAIYI TECHNOLOGY CO.,LTD

China · 惠州 · www.ky-medical.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000010394Unified social credit code 91441322338197162D

This company holds 20 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Singapore, Australia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
20China registrations
Class I 17Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
10UDI-DI device records
Class I 10
USUnited StatesFDA openFDA
3listed device types
Class I 3Class II 0Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 2Class IIa 1
BRBrazilANVISA
7registered devices
Class I 6Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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 Union14 raw hits, 4 excluded, 10 confirmed
United States3 registration records, 0 510(k), 0 PMA
China20 certificates (Class III 0 / II 3 / I 17), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded
Brazil7 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: HUIZHOU KAIYI TECHNOLOGY CO.,LTD · Huizhou Kaiyi Technology Co.LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000010394
EU authorised representative
Umedwings Netherlands B.V.
UK responsible person
Umedwings UK LTD
Unified social credit code
91441322338197162D
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
23
Annual revenue
RMB 50–100M
Website
www.ky-medical.com
Product categories
呼吸、麻醉和急救器械

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
2015-04-10
Registered capital
CNY 2,000,000
Paid-in capital
CNY 1,900,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
General-purpose equipment manufacturing
Last approval date
2024-11-22
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.

FDA listed device types

Exerciser, Non-Measuring 1Blower, Powder, Ent 1Mask, Oxygen 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20242080911一次性使用雾化器Class II
CN粤械注准20162080960一次性使用雾化器Class II
CN粤械注准20162080959一次性使用输氧面罩Class II
CN粤惠械备20240073一次性使用咬嘴Class I
EU06973280043613Breathing TrainerClass I
EU06973280043026Breathing TrainerClass I
EU06973280043606Breathing TrainerClass I
EU06973280040339Medicine chamer spacersClass I
UK31266Breathing TrainerClass I
UK38018Medicine chamber spacersClass I
UK45331Disposable NebulizersClass IIa
BR81596320003MICRONEBULIZADORES ADULTO E INFANTILClass II
BR10410610040ESPAÇADOR PARA MEDICAMENTOS TEC-525Class I
BR10410610041KIT DE MASCARAS PRA MICRONEBULIZADOR ADULTO E INFANTILClass I
SAME0000000310SFDAA00038MEDICINE CHAMBER SPACERS

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