HomeChinaShanghai Berry Electronic Technology Co., Ltd.

Shanghai Berry Electronic Technology Co., Ltd.

China · 上海 · www.berry-med.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000035103Unified social credit code 913101127547839537

This company holds 10 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
10China registrations
Class I 2Class II 8
as of 2026-09-04
EUEuropean UnionEUDAMED
3UDI-DI device records
Class IIa 3
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 5 registration records and 3 510(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 Union79 raw hits, 76 excluded, 3 confirmed
United States5 registration records, 3 510(k), 0 PMA, 1 excluded
China10 certificates (Class III 0 / II 8 / I 2), as of 2026-09-04
United Kingdom0 confirmed, 3 excluded
Brazil1 confirmed, 1 excluded
Manufacturer names merged into this page: SHANGHAI BERRY ELECTRONIC TECH CO., LTD. · SHANGHAI BERRY ELECTRONIC TECH CO., LTD
Same-named companies — This database also contains companies with near-identical names: SHANGHAI BERRY ELETRONIC TECH CO., LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
CN-MF-000035103
EU authorised representative
Prolinx GmbH
Unified social credit code
913101127547839537
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
51
Annual revenue
RMB 50–100M
Website
www.berry-med.com
Product categories
医用电子健康管理

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
2003-09-25
Registered capital
CNY 8,393,015
Paid-in capital
CNY 4,393,190
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Instruments and meters manufacturing
Last approval date
2025-07-04
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative SME

Business registration data from Tianyancha, as of 2026-09-02. 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

12015 · K142687
12018 · K172141
12025 · K250837

FDA listed device types

Oximeter, Wellness 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20262070049多参数监测仪Class II
CN沪械注准20262070047脉搏血氧仪Class II
CN沪械注准20252070238脉搏血氧仪Class II
CN沪械注准20232070006多导呼吸监测仪Class II
EU06924054330026Pulse oximeterClass IIa
EU06924054300470Pulse OximeterClass IIa
EU06924054300463Pulse oximeterClass IIa
USK250837Pulse Oximeter2025-09-25
USK172141Pulse Oximeter2018-04-04
USK142687Pulse Oximeter2015-04-13
BR81464759054Oxímetro de pulsoClass II

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