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Joytech Healthcare Co., Ltd.

China · Hangzhou Zhejiang · www.sejoygroup.com

✓ Record-verifiedregistrations found in 14 marketsEU SRN CN-MF-000006020Unified social credit code 913301000567166303

This company holds 15 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 13 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

15China registrations

Class II 15

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 1Class IIa 299

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

USUnited StatesFDA openFDA

9listed device types

Class I 2Class II 7Class III 0

plus 57 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class IIa 12

BRBrazilANVISA

20registered devices

Class II 20

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

23 including historic records

TWTaiwanTFDA

13valid device licences

Class II 13

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

Import 5

AUAustraliaTGA ARTG

38active ARTG entries

Class I 4IIa 34

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 Union481 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States57 registration records, 23 510(k), 0 PMA

China15 certificates (Class III 0 / II 15 / I 0), as of 2026-09-04

United Kingdom12 confirmed, 0 excluded

Brazil20 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: JOYTECH HEALTHCARE CO., LTD. · JOYTECH HEALTHCARE CO.,LTD. · JOYTECH HEALTHCARE CO.,LTD · JOYTECH Healthcare Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000006020
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 913301000567166303
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2012-12-18
Registered capital: USD 20,000,000
Paid-in capital: USD 20,000,000
Legal form: Limited liability company (wholly owned by a HK/Macao/Taiwan corporation)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-06-11
Recognitions: National 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

32017

32018

42019

22020

22022

12023

22024

32025

32026

FDA listed device types

showing 8 of 9

System, Measurement, Blood-Pressure, Non-Invasive 1Nebulizer (Direct Patient Interface) 1Pump, Breast, Powered 1Oximeter, Wellness 1Clinical Electronic Thermometer 1Continuous Measurement Thermometer 1Thermometer, Clinical Mercury 1Unit, Oral Irrigation 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	浙械注准20262080462	医用雾化器	Class II
CN	浙械注准20262080433	医用压缩式雾化器	Class II
CN	浙械注准20242081757	医用压缩式雾化器	Class II
CN	浙械注准20242071902	红外耳式体温计	Class II
EU	06970392219424	Infrared Ear Thermometer	Class IIa
EU	06970392216508	Wrist-Type Fully Automatic Blood Pressure Monitor	Class IIa
EU	06942284616963	Arm-type Fully Automatic Digital Blood Pressure Monitor	Class IIa
EU	06942284616956	Plusmed Wrist-Type Fully Automatic Blood Pressure Monitor	Class IIa
UK	45617	Blood Pressure Monitors	Class IIa
UK	45617	Blood Pressure Monitors	Class IIa
UK	17887	Infrared Ear Thermometers	Class IIa
US	K253425	Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)	2026-08-13
US	K252501	Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)	2026-04-28
US	K252685	Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)	2026-02-13
BR	10410610032	MONITOR DE PRESSÃO ARTERIAL DIGITAL AUTOMATICO DE BRAÇO	Class II
BR	10410610033	MONITOR DE PRESSÃO ARTERIAL DIGITAL AUTOMATICO DE PULSO	Class II
BR	80275310065	Aparelho de Pressão Digital Premium	Class II
SA	ME0000001466SFDAA00011	manual breast pump	—