HomeChinaBORSAM Biomedical Instruments Co.,Ltd.

BORSAM Biomedical Instruments Co.,Ltd.

China · 深圳 · www.bioxtime.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000023994Unified social credit code 914403006911543153

This company holds 10 NMPA certificates in China and has registrations in European Union, Australia, Israel — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 3Class II 7
as of 2026-09-04
EUEuropean UnionEUDAMED
10UDI-DI device records
Class IIa 10
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(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
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union10 raw hits, 0 excluded, 10 confirmed
China10 certificates (Class III 0 / II 7 / I 3), as of 2026-09-04

Regulatory identity

EU manufacturer SRN
CN-MF-000023994
EU authorised representative
Kingsmead Service B.V.
Unified social credit code
914403006911543153
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
25
Annual revenue
RMB 10–30M
Website
www.bioxtime.com
Product categories
医用电子医用诊察和监护器械

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
2009-06-30
Registered capital
CNY 4,642,857
Paid-in capital
CNY 4,642,857
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-05-09
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20232070764动态心电血压血氧记录仪Class II
CN粤械注准20212071046心电图机工作站Class II
CN粤械注准20212070923动态心电图记录器Class II
CN粤械注准20212070354动态心电血压记录仪Class II
EU06934666200013ECG Event RecorderClass IIa
EU06934666200167ECG Event RecorderClass IIa
EU06934666200228ECG Event RecorderClass IIa
EU06934666200150Ambulatory Blood Pressure Measurement SystemClass IIa

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