HomeChinaShenzhen Jermei Medical Device Technology Co.,Ltd.

Shenzhen Jermei Medical Device Technology Co.,Ltd.

China · 深圳 · www.szjermei.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000039164Unified social credit code 91440300MA5FG64GXF

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

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class I 2Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
52UDI-DI device records
Class IIa 52
USUnited StatesFDA openFDA
4listed device types
Class I 3Class II 1Class III 0
plus 4 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
BRBrazilANVISA
0registered devices
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
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union52 raw hits, 0 excluded, 52 confirmed
United States4 registration records, 1 510(k), 0 PMA
China4 certificates (Class III 0 / II 2 / I 2), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN JERMEI MEDICAL DEVICE TECHNOLOGY CO.,LTD · Shenzhen Jermei Medical Device Technology Co.,Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000039164
EU authorised representative
Luxus Lebenswelt GmbH
UK responsible person
JKN Capital & Property Ltd
Unified social credit code
91440300MA5FG64GXF
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
74
Annual revenue
RMB 50–100M
Website
www.szjermei.com

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
2019-01-25
Registered capital
CNY 13,300,000
Paid-in capital
CNY 13,300,000
Legal form
Limited liability company
Industry classification
Electrical machinery and equipment
Last approval date
2025-03-12
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 510(k) clearances by year

12025 · K244035

FDA listed device types

Toothbrush, Powered 1Massager, Therapeutic, Electric 1Mask, Oxygen 1Nebulizer (Direct Patient Interface) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20242070664全自动臂式电子血压计Class II
CN粤械注准20202081706网式雾化器Class II
CN粤深械备20200448号医用隔离面罩Class I
CN粤深械备20200447号医用隔离眼罩Class I
EU06972433811055Portable Mesh NebulizerClass IIa
EU06972433811208Portable Mesh NebulizerClass IIa
EU06972433810232Portable Mesh NebulizerClass IIa
EU06972433810225Portable Mesh NebulizerClass IIa
UK66295Alypri Rechargeable Handheld NebulizerClass IIa
UK66295Ultrasound NebulizerClass IIa
USK244035Portable mesh nebulizer (JM821)2025-09-19
SAME0000000952SFDAA00002Wixana

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