HomeChinaZhuhai Dipu Medical Technology Co., Ltd.

Zhuhai Dipu Medical Technology Co., Ltd.

China · 珠海 · www.digipmc.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000037294Unified social credit code 91440400MA52PR155U

This company holds 37 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
37China registrations
Class II 37
as of 2026-09-04
EUEuropean UnionEUDAMED
6UDI-DI device records
Class IIa 6
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 Union6 raw hits, 0 excluded, 6 confirmed
United States2 registration records, 2 510(k), 0 PMA
China37 certificates (Class III 0 / II 37 / I 0), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: ZHUHAI DIPU MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000037294
EU authorised representative
PureCE B.V.
Unified social credit code
91440400MA52PR155U
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
140
Annual revenue
RMB 50–100M
Website
www.digipmc.com
Product categories
医用成像器械

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
2018-12-28
Registered capital
CNY 150,000,000
Paid-in capital
CNY 120,000,000
Legal form
Limited liability company (wholly owned by a natural-person-controlled corporation)
Industry classification
Research and experimental development
Last approval date
2026-05-13
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. 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

22024 · K233840

FDA listed device types

System, X-Ray, Angiographic 1Laparoscope, General & Plastic Surgery 1System, Surgical, Computer Controlled Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262060510胸腹腔内窥镜Class II
CN粤械注准20262060070三维荧光电子胸腹腔内窥镜Class II
CN粤械注准20252210335医学影像处理软件Class II
CN粤械注准20252061692内窥镜用冷光源Class II
EU06975689750420Endoscopic Fluorescence Camera SystemClass IIa
EU06975689750529Fluorescence EndoscopesClass IIa
EU06975689750512Fluorescence EndoscopesClass IIa
EU06975689750482Fluorescence EndoscopesClass IIa
USK233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)2024-06-26
USK2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)2024-06-13
BR81325999081Sistema de Câmera de Fluorescência EndoscópicaClass II

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