Home›China›Biobase Biodustry (Shandong)Co.,Ltd

Biobase Biodustry (Shandong)Co.,Ltd

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000025015Unified social credit code 91370100MA3RJG119H

This company holds 3 NMPA certificates in China and has registrations in European Union, United States, Brazil, Australia, Russia — 5 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

3China registrations

Class I 3

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

IVD general 300

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

USUnited StatesFDA openFDA

70listed device types

Class I 56Class II 14Class III 0

plus 70 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

30registered devices

Class I 5Class II 25

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

8active registrations

Class 2a 8

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 Union2,283 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States70 registration records, 0 510(k), 0 PMA

China3 certificates (Class III 0 / II 0 / I 3), as of 2026-09-04

Brazil30 confirmed, 0 excluded

Manufacturer names merged into this page: BIOBASE BIODUSTRY(SHANDONG)CO., LTD · BIOBASE BIODUSTRY (SHANDONG) CO., LTD · BIOBASE BIODUSTRY (SHANDONG) CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000025015
EU authorised representative: Luxus Lebenswelt GmbH
Unified social credit code: 91370100MA3RJG119H
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

FDA listed device types

showing 8 of 70

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine 1Biuret (Colorimetric), Total Protein 1Lowry (Colorimetric), Total Protein 1Factor B, Antigen, Antiserum, Control 1System, Test, Beta-2-Microglobulin Immunological 1Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes 1Real Time Nucleic Acid Amplification System 1Radioassay, Angiotensin Converting Enzyme 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	鲁济械备20200136号	全自动核酸提取仪	Class I
CN	鲁济械备20200076号	核酸提取仪	Class I
CN	鲁济械备20200076	核酸提取仪	Class I
EU	06936895315636	Sialic Acid (SA) Test Kit (Neuraminidase enzymic)	IVD general
EU	06936895315629	Sialic Acid (SA) Test Kit (Neuraminidase enzymic)	IVD general
EU	06936895315612	Sialic Acid (SA) Test Kit (Neuraminidase enzymic)	IVD general
EU	06936895315605	Sialic Acid (SA) Test Kit (Neuraminidase enzymic)	IVD general
BR	80805750003	Família Analisador Hematológico	Class II
BR	80805750002	Analisador Hematológico	Class II
BR	82832860049	ANALISADOR AUTOMÁTICO DE HEMATOLOGIA BK-3200	Class II

Biobase Biodustry (Shandong)Co.,Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

Similar companies