HomeChinaShenzhen Delica Medical Equipment Co., Ltd.

Shenzhen Delica Medical Equipment Co., Ltd.

China · Shenzhen Guangdong · www.delicamed.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000022543Unified social credit code 91440300708451536R

This company holds 19 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Hong Kong — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
19China registrations
Class II 18Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
12UDI-DI device records
Class IIa 12
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 5Class III 0
plus 6 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class IIa 3Class IIb 2
BRBrazilANVISA
1registered devices
Class II 1
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
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
4valid listings
Class II 4
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 Union12 raw hits, 0 excluded, 12 confirmed
United States6 registration records, 3 510(k), 0 PMA
China19 certificates (Class III 1 / II 18 / I 0), as of 2026-09-04
United Kingdom5 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000022543
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Wellkang Ltd
Unified social credit code
91440300708451536R
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shenzhen Guangdong
Social-insurance enrolees
111
Annual revenue
under RMB 5M
Website
www.delicamed.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsUltrasound (POCUS, AI-guided, portable)

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
1998-09-17
Registered capital
CNY 46,590,000
Paid-in capital
CNY 20,350,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Rubber and plastic products
Last approval date
2026-03-05
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseManufacturing Single ChampionTorch Programme enterpriseAbove-designated-size industrial enterprise
Listing
Delisted from the NEEQ

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

12018 · K173801
12019 · K190228
12022 · K213009

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Measurement, Blood-Pressure, Non-Invasive 1Diagnostic Ultrasonic Transducer, Robotic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Blood Pressure Cuff 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263071298超声多普勒血流分析仪Class III
CN粤械注准20262090320经颅磁刺激仪Class II
CN粤械注准20242210692脑血流调节功能数据处理软件Class II
CN粤械注准20232210113脑电工作站软件Class II
EU06970481940161DELICAClass IIa
EU06970481940178DELICAClass IIa
EU06970481940086DELICAClass IIa
EU06970481940079DELICAClass IIa
UK41920Depth of Anesthesia MonitorClass IIb
UK17942Cerebral-Somatic Oximetry SystemClass IIa
UK11467Electroencephalo graph (EEG)Class IIa
USK213009Transcranial Doppler Ultrasound System2022-07-08
USK190228Transcranial Doppler Ultrasound System2019-06-13
USK173801Transcranial Doppler Ultrasound System2018-07-11
BR10263619025Sistema de Ultrassom Doppler Transcraniano DelicaClass II

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