HomeChinaDakewe (Shenzhen) Medical Equipment Co, Ltd

Dakewe (Shenzhen) Medical Equipment Co, Ltd

China · Shenzhen Guangdong · www.dakewemedical.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000009696Unified social credit code 914403003599600674

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel, Russia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
12China registrations
Class I 12
as of 2026-09-04
EUEuropean UnionEUDAMED
31UDI-DI device records
IVD A 31
USUnited StatesFDA openFDA
9listed device types
Class I 9Class II 0Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
9registered device records
IVD general 9
BRBrazilANVISA
8registered devices
Class I 8
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
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 1 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
8active registrations
Class 2a 8
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 Union82 raw hits, 51 excluded, 31 confirmed
United States9 registration records, 0 510(k), 0 PMA, 2 excluded
China12 certificates (Class III 0 / II 0 / I 12), as of 2026-09-04
United Kingdom9 confirmed, 1 excluded
Brazil8 confirmed, 1 excluded
Manufacturer names merged into this page: DAKEWE(SHENZHEN) MEDICAL EQUIPMENT CO., LTD · DAKEWE (SHENZHEN) MEDICAL EQUIPMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000009696
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
914403003599600674
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
City
Shenzhen Guangdong
Social-insurance enrolees
234
Annual revenue
over RMB 500M
Website
www.dakewemedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsLaboratory automation & robotics

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
2016-01-28
Registered capital
CNY 60,000,000
Paid-in capital
CNY 60,000,000
Legal form
Limited liability company (wholly corporate-owned)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-12-18
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based 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 listed device types

showing 8 of 9
Microtome, Cryostat 1Device For Sealing Microsections 1Slides, Microscope 1Container, Embedding 1Microtome, Rotary 1Coverslips, Microscope Slide 1Slide Stainer, Automated 1Processor, Tissue, Automated 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤深械备20260597冷冻切片机Class I
CN粤深械备20240877轮转式切片机Class I
CN粤深械备20240679全自动染色封片机Class I
CN粤深械备20240455封片机Class I
EU06971182571531Paraffin WaxIVD A
EU06971182571524CT620 Cryostat MicrotomeIVD A
EU06971182571449Automatic Tissue ProcessorIVD A
EU06971182571326NS40 Fully Automated IHC StainerIVD A
UK15157Cryostat MicrotomeIVD general
UK57925Adhesion Microscope SlidesIVD general
UK15687Microscope cover glassIVD general
BR80430080023Família de Corador IHC Totalmente AutomatizadoClass I
BR80430080024Processador Automático de Tecidos HP-HUGOClass I
BR80430080011CRIOSTATO 6250Class I

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