HomeChinaShenzhen Pump Medical System Co., Ltd

Shenzhen Pump Medical System Co., Ltd

China · 深圳 · www.bpumpmedical.com.cn
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000031216Unified social credit code 91440300796638463C

This company holds 7 NMPA certificates in China and has registrations in European Union, United States, South Korea, Australia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class I 6Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
16UDI-DI device records
Class I 14Class IIa 2
USUnited StatesFDA openFDA
7510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 7 510(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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Manufacturing 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
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 Union23 raw hits, 7 excluded, 16 confirmed
United States0 registration records, 7 510(k), 0 PMA, 1 excluded
China7 certificates (Class III 0 / II 1 / I 6), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000031216
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91440300796638463C
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
37
Annual revenue
RMB 50–100M
Website
www.bpumpmedical.com.cn

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
2007-01-26
Registered capital
CNY 24,132,718
Paid-in capital
CNY 24,132,718
Legal form
Limited liability company
Industry classification
Other manufacturing
Last approval date
2020-04-23
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative 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

12013 · K130325
22014 · K141416
12015 · K151810
22016 · K161708
12017 · K161712

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20192090718间歇式气动压力治疗仪Class II
CN粤深械备20251268造口底盘Class I
CN粤深械备20251137造口袋Class I
CN粤深械备20251089造口袋Class I
EU06947679702610Limb Pressure SleeveClass I
EU06947679702559Limb Pressure SleeveClass I
EU06947679702634Limb Pressure SleeveClass I
EU06947679701866Limb Pressure SleeveClass I
USK161712Arm automatic blood pressure monitor2017-04-05
USK161708Arm automatic blood pressure monitor2016-11-22
USK151258Arm automatic blood pressure monitor2016-02-18

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