Home›China›Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000034581Unified social credit code 91440300279256539X

This company holds 19 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 10 overseas markets. EU UDI-DI records ≥283, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

19China registrations

Class II 19

as of 2026-09-04

EUEuropean UnionEUDAMED

≥283UDI-DI device records

IVD A 49IVD general 234

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

USUnited StatesFDA openFDA

17listed device types

Class I 11Class II 4Class III 1unclassified 1

plus 20 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

211registered device records

IVD A 22IVD C 1IVD general 188

BRBrazilANVISA

18registered devices

Class I 7Class II 11

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

235active device licences

Class II 235

334 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

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 Union3,959 raw hits, 17 excluded, 283 confirmed. Large result set — only the first 300 verified

United States20 registration records, 6 510(k), 0 PMA, 21 excluded

China19 certificates (Class III 0 / II 19 / I 0), as of 2026-09-04

United Kingdom211 confirmed, 1 excluded

Brazil18 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada235 confirmed, 3 excluded

Manufacturer names merged into this page: BIOCARE MEDICAL, LLC · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. · BIOCARE MEDICAL LLC · BIOCARE MEDICAL

Regulatory identity

EU manufacturer SRN: US-MF-000034581
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited
Unified social credit code: 91440300279256539X
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1996-07-15
Registered capital: CNY 63,300,000
Paid-in capital: CNY 63,300,000
Legal form: Joint-stock limited company (unlisted)
Industry classification: Wholesale trade
Last approval date: 2023-05-18
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseSRDI 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

12014 · K132758

32015 · K152384

12016 · K160092

12018 · K171517

FDA listed device types

showing 8 of 17

System, Test, Her-2/Neu, Ihc 1Electrocardiograph 1Monitor, Ultrasonic, Fetal 1Immunohistochemistry Assay, Antibody, Progesterone Receptor 1Immunohistochemistry Antibody Assay, Estrogen Receptor 1Epstein-Barr Virus, Other 1Immunohistochemistry Reagents And Kits 1Reagents, Specific, Analyte 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20252070117	脉搏血氧仪	Class II
CN	粤械注准20222211572	生理信号处理软件	Class II
CN	粤械注准20192070053	心电工作站	Class II
CN	粤械注准20182070690	动态心电/血压记录仪	Class II
EU	00847627028570	HLA-DR [TAL 185]	IVD general
EU	00847627007728	HIF-1 alpha	IVD general
EU	00847627007711	HIF-1 alpha	IVD general
EU	00847627011718	URO-3 Triple Stain w/CK20	IVD general
UK	49871	IgG4 (M)	IVD general
UK	65252	ATRX	IVD general
UK	56770	Alpha-1-Fetoprotein (AFP)	IVD general
US	K171517	Digital Electrocardiograph	2018-01-11
US	K160092	Digital Electrocardiograph	2016-02-12
US	K152384	Digital Electrocardiograph	2015-12-18
BR	80102519247	ELETROCARDIÓGRAFO DIGITAL	Class II
BR	80071430023	CORADOR DE LAMINA PAEA IMUNOHISTOQUIMICA	Class I
BR	80071430012	Biocare IHQ - Marcadores Complementares III	Class II
CA	80974	LEUKOCYTE COMMON ANTIGEN (LCA) COCKTAIL	Class II
CA	80977	S100 PROTEIN COCKTAIL	Class II
CA	81082	MACH4 UNIVERSAL AP POLYMER	Class II