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Sunny Medical Device (Shenzhen) Co., Ltd.

China · Shenzhen Guangdong · www.sunnymedical.com.cn

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000022722Unified social credit code 914403007488755871

This company holds 14 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel — 10 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

14China registrations

Class II 10Class III 4

as of 2026-09-04

EUEuropean UnionEUDAMED

94UDI-DI device records

Class I 21Class IIa 73

USUnited StatesFDA openFDA

11listed device types

Class I 2Class II 9Class III 0

plus 12 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

35registered devices

Class I 6Class II 29

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

5 including historic records

TWTaiwanTFDA

13valid device licences

Class II 13

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1Class Is (sterile) 1

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

2registrations

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 Union178 raw hits, 84 excluded, 94 confirmed

United States12 registration records, 6 510(k), 0 PMA, 5 excluded

China14 certificates (Class III 4 / II 10 / I 0), as of 2026-09-04

United Kingdom1 confirmed, 2 excluded

Brazil35 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Manufacturer names merged into this page: SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. · SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD. · SUNNY MEDICAL DEVICES (SCHENZHEN)

Regulatory identity

EU manufacturer SRN: CN-MF-000022722
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: LFH Regulatory Limited
Unified social credit code: 914403007488755871
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2003-04-16
Registered capital: CNY 6,000,000
Paid-in capital: CNY 6,000,000
Legal form: Limited liability company
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-04-25
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-01. 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

12012 · K120119

12014 · K133795

12015 · K140356

22016 · K160190

12020 · K191827

FDA listed device types

showing 8 of 11

Wire, Guide, Catheter 1Syringe, Balloon Inflation 1Wire, Guide, Catheter, Exempt 1Trocar 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Injector And Syringe, Angiographic 1Syringe, Balloon Inflation, Exempt 1Catheter, Intravascular, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20183030053	一次性使用Y型连接器套件	Class III
CN	国械注准20173030843	一次性使用环柄注射器	Class III
CN	国械注准20163141177	一次性使用肝素帽	Class III
CN	国械注准20153142007	一次性使用医用连通器	Class III
EU	06947358524311	Sunmed™ pressure lines	Class IIa
EU	06947358552956	Sunmed™ manifold and stopcocks	Class IIa
EU	06947358553960	Sunmed™ manifold and stopcocks	Class IIa
EU	06947358553977	Sunmed™ manifold and stopcocks	Class IIa
UK	36079	Sunmed™ haemostatic valve	Class IIa
US	K191827	Sunmed Disposable Angio-Closure Pads	2020-03-16
US	K160190	Sunmed Control Syringes	2016-11-10
US	K153685	Sunmed Haemostatic Valves	2016-10-13
BR	83288319007	BASKET DE EXTRAÇÃO DE CÁLCULO EM NITINOL Sunnymed	Class II
BR	83288319008	Kits de cateter duplo J SUNNYMED	Class II
BR	83288319009	Kit Nefrostomia Percutânea Sunnymed	Class II