HomeChinaBaisheng Medical Co., Ltd.

Baisheng Medical Co., Ltd.

China · Jiangmen Guangdong · www.obs-medical.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000024558Unified social credit code 914407057341275614

This company holds 18 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Australia, Israel, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
18China registrations
Class I 4Class II 11Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
132UDI-DI device records
Class I 23Class IIa 19Class IIb 90
USUnited StatesFDA openFDA
4listed device types
Class I 1Class II 3Class III 0
plus 12 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class I 1Class IIa 2Class IIb 4
BRBrazilANVISA
4registered devices
Class I 1Class II 3
10 including historic records
SASaudi ArabiaSFDA
2registered 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
6active ARTG entries
Class I 4IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 1Class 2b 1
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 Union132 raw hits, 0 excluded, 132 confirmed
United States12 registration records, 8 510(k), 0 PMA
China18 certificates (Class III 3 / II 11 / I 4), as of 2026-09-04
United Kingdom7 confirmed, 0 excluded
Brazil4 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: BAISHENG MEDICAL CO.,LTD. · BAISHENG MEDICAL CO LTD · JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO., LTD. · Baisheng Medical Co., Ltd. · BAISHENG MEDICAL CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000024558
EU authorised representative
Gardien Limited
UK responsible person
Wellkang Ltd
Unified social credit code
914407057341275614
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Jiangmen Guangdong
Social-insurance enrolees
227
Annual revenue
RMB 50–100M
Website
www.obs-medical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
2001-12-05
Registered capital
CNY 22,837,500
Paid-in capital
CNY 14,500,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-07-28
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative SMEAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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

12009
12010
12016
12017
12022
12024
22025

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Staple, Removable (Skin) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20223010118高频内窥镜手术器械Class III
CN国械注准20183011785高频电刀Class III
CN国械注准20173011560高频手术设备Class III
CN粤械注准20252070580一次性使用无创脑电传感器Class II
EU06939411509564Defibrillation ElectrodeClass I
EU08427297285408GROUNDING PLATE CABLEClass I
EU08427297160651GROUNDING PLATE CABLEClass I
EU06939411511192Disposable ECG ElectrodesClass I
UK44681Electrosurgical electrodeClass IIb
UK58494Electrosurgical electrodeClass IIb
UK11490Electrosurgical generator & AccessoryClass IIb
USK250841Electrotherapy Electrodes2025-08-13
USK251235Electrosurgical Pads2025-06-19
USK233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 12024-01-08
BR80722809001Trocater Descartável sem lâmina BluepadClass II
BR80722809002Trocater Descartável com lâmina BluepadClass II
BR80151490040ELETRODOS PARA ECG OBSClass II
SAME0000006522SFDAA00001Electrotherapy TENS
SAME0000005770SFDAA00002OBS

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