HomeChinaGuangdong Baihe Medical Technology Co., Ltd.

Guangdong Baihe Medical Technology Co., Ltd.

China · Foshan Guangdong · www.baihemedical.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000022962Unified social credit code 91440600721123254C

This company holds 53 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Hong Kong, Russia — 9 overseas markets. EU UDI-DI records ≥172, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
53China registrations
Class I 6Class II 24Class III 23
as of 2026-09-04
EUEuropean UnionEUDAMED
≥172UDI-DI device records
Class IIa 59Class IIb 113
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
4listed device types
Class I 1Class II 3Class III 0
plus 4 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class IIa 3Class III 2
BRBrazilANVISA
27registered devices
Class I 6Class II 21
32 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
Class III 1IIa 8IIb 1
HKHong KongMDACS
15valid listings
Class II 10Class III 3Class IV 2
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
5active registrations
Class 2a 2Class 2b 1Class 3 2
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 Union676 raw hits, 128 excluded, 172 confirmed. Large result set — only the first 300 verified
United States4 registration records, 1 510(k), 0 PMA
China53 certificates (Class III 23 / II 24 / I 6), as of 2026-09-04
United Kingdom5 confirmed, 1 excluded
Brazil27 confirmed, 1 excluded
Manufacturer names merged into this page: GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD · GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD. · Guangdong Baihe Medical Technology Co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000022962
EU authorised representative
Share info GmbH
UK responsible person
CMC Medical Devices LTD
Unified social credit code
91440600721123254C
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Foshan Guangdong
Social-insurance enrolees
1,848
Annual revenue
over RMB 500M
Website
www.baihemedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentOperating room infrastructure

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
1999-11-01
Registered capital
CNY 90,000,000
Paid-in capital
CNY 90,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Rubber and plastic products
Last approval date
2023-01-04
Recognitions
National High-Tech EnterpriseRecognised enterprise technology centreAbove-designated-size industrial enterprise

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

12013 · K130908

FDA listed device types

Catheter, Retention Type, Balloon 1Catheter, Hemodialysis, Non-Implanted 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Dressing, Wound, Hydrophilic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263100823一次性使用血液透析器Class III
CN国械注准20263030820经外周中心静脉导管及附件Class III
CN国械注准20253141113一次性使用输液延长管Class III
CN国械注准20253021254一次性使用不可吸收闭合夹Class III
EU06938634477322Disposable Drainage Catheters KitClass IIa
EU06938634477384Disposable Drainage Catheters KitClass IIa
EU06938634477391Disposable Drainage Catheters KitClass IIa
EU06938634477414Disposable Drainage Catheters KitClass IIa
UK61594Central Venous Catheter KitClass III
UK61630Haemodialysis Catheter KitClass III
UK47796Disposable Drainage Catheters and AccessoriesClass IIa
USK130908DISPOSABLE SILICONE FOLEY CATHETER2013-10-03
BR81231550009Cateter Foley Total LifeClass II
BR80415440017Kit de Cateterização Mono LúmenClass II
BR80415440020Kit de Cateterização de Lúmen TriploClass II

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