HomeChinaShenzhen Raycome Health Technology CO., Co., Ltd.

Shenzhen Raycome Health Technology CO., Co., Ltd.

China · Shenzhen · www.raycome.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000033181Unified social credit code 91440300672986933D

This company holds 16 NMPA certificates in China and has registrations in European Union, United States, Taiwan, Israel — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
16China registrations
Class I 1Class II 15
as of 2026-09-04
EUEuropean UnionEUDAMED
6UDI-DI device records
Class IIa 6
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 3 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
1valid device licences
Class II 1
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 Union6 raw hits, 0 excluded, 6 confirmed
United States3 registration records, 0 510(k), 0 PMA
China16 certificates (Class III 0 / II 15 / I 1), as of 2026-09-04
Manufacturer names merged into this page: SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000033181
EU authorised representative
Lotus NL B.V.
Unified social credit code
91440300672986933D
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shenzhen
Social-insurance enrolees
0
Annual revenue
RMB 50–100M
Website
www.raycome.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentCardiology & vascular medicine

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
2008-04-16
Registered capital
CNY 39,350,693
Paid-in capital
CNY 39,350,693
Legal form
Limited liability company
Industry classification
Technology promotion and application services
Last approval date
2025-12-18
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle 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

Massager, Therapeutic, Electric 1Plethysmograph, Photoelectric, Pneumatic Or Hydraulic 1System, Measurement, Blood-Pressure, Non-Invasive 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262070895脉搏波医用血压计Class II
CN粤械注准20242071328医用动态血压监测仪Class II
CN粤械注准20242071140脉搏波医用血压计Class II
CN粤械注准20242071098脉搏波医用全自动血压计Class II
EU06954160100503RaycomeClass IIa
EU06954160100107RaycomeClass IIa
EU06954160100237RaycomeClass IIa
EU06954160100190RaycomeClass IIa

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