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Bain Medical Equipment (Guangzhou) Co., Ltd.

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000005196Unified social credit code 91440101MA59AJME5G

This company holds 16 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

16China registrations

Class I 9Class II 2Class III 5

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class IIa 191Class IIb 109

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 5 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 2Class IIb 3

BRBrazilANVISA

36registered devices

Class I 1Class II 35

41 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

13GMP quality-system certificates

Import 10Manufacturing 3

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

3valid listings

Class II 2Class III 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 3

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 Union950 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States5 registration records, 7 510(k), 0 PMA

China16 certificates (Class III 5 / II 2 / I 9), as of 2026-09-04

United Kingdom5 confirmed, 0 excluded

Brazil36 confirmed, 1 excluded

Manufacturer names merged into this page: BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD. · BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD. · BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD · BAIN MEDICAL EQUIPMENT (GUANGHZOU) CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000005196
EU authorised representative: Medical Technology Promedt Consulting GmbH
UK responsible person: Medimap Ltd
Unified social credit code: 91440101MA59AJME5G
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2015-10-29
Registered capital: CNY 20,000,000
Paid-in capital: CNY 5,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-05-07
Recognitions: Micro and small enterpriseNational High-Tech 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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263140466	一次性使用泵用静脉输液套件	Class III
CN	国械注准20263081690	一次性使用超声引导麻醉穿刺套件	Class III
CN	国械注准20263081557	超声引导腰麻硬膜外麻醉穿刺套件	Class III
CN	国械注准20223080691	超声引导麻醉穿刺针	Class III
EU	06948082700903	DORA Hollow Fiber Dialyzer	Class IIb
EU	06948082700910	DORA Hollow Fiber Dialyzer	Class IIb
EU	06948082703775	DORA Hollow Fiber Dialyzer	Class IIb
EU	06948082703560	DORA Hollow Fiber Dialyzer	Class IIb
UK	34999	Tubing Sets for Hemodialysis	Class IIa
UK	35849	Hemodialysis Bicarbonate	Class IIb
UK	12741	Disposable A.V. Fistula Needle Sets	Class IIa
US	K252423	NovaLine Tubing Set for Hemodialysis (BL 124)	2026-05-15
US	K240164	NovaLine SP-C35 Transducer Protector (956007)	2024-06-28
US	K213015	DORA Disposable A.V. Fistula Needle Sets	2022-04-08
BR	81504799049	Jogo de agulhas descartáveis para fístula arterio-venosa	Class II
BR	80133950101	Set de Linhas de Sangue para Hemodiálise Arterial sem Catabolha + Veno	Class II
BR	80133950102	Set de Linhas de Sangue para Hemodiálise Arterial com Catabolha + Veno	Class II

Bain Medical Equipment (Guangzhou) Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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