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BMC Medical Co., Ltd.

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000010157Unified social credit code 9111010872636740X9

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. No China NMPA registrations were found.

Registrations by market

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

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

221UDI-DI device records

Class IIa 218Class IIb 3

USUnited StatesFDA openFDA

5listed device types

Class I 2Class II 3Class III 0

plus 43 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

25registered device records

Class IIa 24Class IIb 1

BRBrazilANVISA

23registered devices

Class II 23

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

9 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

30device registrations

CLASS B 28CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

12active ARTG entries

IIa 9IIb 3

HKHong KongMDACS

9valid listings

Class II 9

ILIsraelAMAR

13registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 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 Union226 raw hits, 5 excluded, 221 confirmed

United States43 registration records, 7 510(k), 0 PMA, 2 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom25 confirmed, 0 excluded

Brazil23 confirmed, 0 excluded

Manufacturer names merged into this page: BMC MEDICAL CO., LTD. · BMC (Tianjin) Medical Co., Ltd. · BMC(Dongguan) Medical Co., Ltd. · BMC MEDICAL MANUFACTURING S.A. DE C.V. · BMC MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000010157
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Wellkang Ltd
Unified social credit code: 9111010872636740X9
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12014 · K133009

12017 · K163464

22022 · K213169

12025 · K242935

22026 · K260171

FDA listed device types

Ventilator, Continuous, Non-Life-Supporting 1Catheter, Percutaneous 1Ventilator, Non-Continuous (Respirator) 1Instrument, Manual, Surgical, General Use 1Set, Tubing And Support, Ventilator (W Harness) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06948538360286	F2 NV Full Face Mask	Class IIa
EU	06948538360279	F2 NV Full Face Mask	Class IIa
EU	06948538360262	F2 NV Full Face Mask	Class IIa
EU	06948538360255	F2 NV Full Face Mask	Class IIa
UK	57814	F1B Full Face Mask	Class IIa
UK	57814	Mask (Trade Name: Nasal Mask, Full Face Mask, Nasal Pillows Interface)	Class IIa
UK	57813	F2 NV Full Face Mask	Class IIa
US	K260171	Portable Oxygen Concentrator (PO1 5B, PO1 6B)	2026-08-14
US	K253166	F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)	2026-04-29
US	K242935	Respiration Data Management Software (PAP Link PC)	2025-01-15
BR	81464759032	Respiratory High-Flow Therapy Device	Class II
BR	80047309235	BMC Mask	Class II
BR	80047309236	BMC Mask	Class II