Biobase Biodustry(Shandong) Co.,Ltd.

SRN: CN-MF-000025015 · Mingshui Economic Devlopment Zone, Zhangqiu Dsitrict, 250000 Jinan City, China

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Mingshui Economic Devlopment Zone, Zhangqiu Dsitrict, 250000 Jinan City, China
Email: [email protected]

Regulatory Overview

Regulation

Eu Ivdr 14

Eu Mdr 3

Classification

Eu Ivd Class A 14

Eu Md Class 1 3

Device Types

Certificate Health

No certificates registered for this manufacturer.

Device Portfolio

Name	Regulation	Classification	Market Status
5-Part Auto Hematology Analyzer	EU IVDR	Eu Ivd Class A	On Market
5-Part Auto Hematology Analyzer	EU IVDR	Eu Ivd Class A	On Market
5-Part Auto Hematology Analyzer	EU IVDR	Eu Ivd Class A	On Market
AUTOMATED 3 PART HEMATOLOGY ANALYSERS	EU IVDR	Eu Ivd Class A	On Market
AUTOMATED COAGULOMETERS	EU IVDR	Eu Ivd Class A	On Market
AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)	EU IVDR	Eu Ivd Class A	On Market
AUTOSAMPLERS	EU IVDR	Eu Ivd Class A	On Market
AUTOSAMPLERS	EU IVDR	Eu Ivd Class A	On Market
AUTOSAMPLERS	EU IVDR	Eu Ivd Class A	On Market
AUTOSAMPLERS	EU IVDR	Eu Ivd Class A	On Market
AUTOSAMPLERS	EU IVDR	Eu Ivd Class A	On Market
AUTOSAMPLERS	EU IVDR	Eu Ivd Class A	On Market
Auto Hematology Analyzer	EU IVDR	Eu Ivd Class A	On Market
Auto Hematology Analyzer	EU IVDR	Eu Ivd Class A	On Market
Automatic Chemistry Analyzer	EU IVDR	Eu Ivd Class A	On Market
Automatic Nucleic Acid Extraction System	EU IVDR	Eu Ivd Class A	On Market
Automatic Nucleic Acid Extraction System	EU IVDR	Eu Ivd Class A	On Market
Automatic chemistry analyzer	EU IVDR	Eu Ivd Class A	On Market
BIOLOGICAL HOODS	EU MDR	Eu Md Class 1	On Market
BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)	EU IVDR	Eu Ivd Class A	On Market
Biological Safety Cabinet	EU MDR	Eu Md Class 1	On Market
Biological Safety Cabinet	EU MDR	Eu Md Class 1	On Market
Biological Safety Cabinet	EU MDR	Eu Md Class 1	On Market
Biological Safety Cabinet	EU MDR	Eu Md Class 1	On Market
Biological Safety Cabinet	EU MDR	Eu Md Class 1	On Market
Biological Safety Cabinet	EU MDR	Eu Md Class 1	On Market
Blood Coagulation Analyzer	EU IVDR	Eu Ivd Class A	On Market
Blood Coagulation Analyzer	EU IVDR	Eu Ivd Class A	On Market
Blood Coagulation Analyzer	EU IVDR	Eu Ivd Class A	On Market
Blood Coagulation Analyzer	EU IVDR	Eu Ivd Class A	On Market
Blood Coagulation Analyzer	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)	EU IVDR	Eu Ivd Class A	On Market
CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)	EU IVDR	Eu Ivd Class A	On Market
ERYTHROCYTE SEDIMENTATION RATE DEVICES	EU IVDR	Eu Ivd Class A	On Market
Electrolyte Analyzer	EU IVDR	Eu Ivd Class A	On Market
Electrolyte Analyzer	EU IVDR	Eu Ivd Class A	On Market
Electrolyte Analyzer	EU IVDR	Eu Ivd Class A	On Market
Elisa Microplate Reader	EU IVDR	Eu Ivd Class A	On Market
Elisa Plate Reader	EU IVDR	Eu Ivd Class A	On Market
IMMUNOCHEMISTRY READERS	EU IVDR	Eu Ivd Class A	On Market
IMMUNOCHEMISTRY READERS	EU IVDR	Eu Ivd Class A	On Market
IMMUNOCHEMISTRY READERS	EU IVDR	Eu Ivd Class A	On Market
INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER	EU IVDR	Eu Ivd Class A	On Market

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