B&E BIO-TECHNOLOGY CO., LTD.

SRN: CN-MF-000023256 · No.11 Jieaisi Road,Laishan District,Yantai City, 264003 Shandong Province, China

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: No.11 Jieaisi Road,Laishan District,Yantai City, 264003 Shandong Province, China
Email: [email protected]

Regulatory Overview

Regulation

Eu Ivdd 10

Eu Ivdr 4

Classification

Eu Ivd General 10

Eu Ivd Class A 4

Device Types

Certificate Health

No certificates registered for this manufacturer.

Market Presence

Devices from this manufacturer are available in 32 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

Device Portfolio

Name	Regulation	Classification	Market Status
AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE	EU IVDD	Eu Ivd General	On Market
BLOOD GAS ANALYSERS - CONSUMABLES	EU IVDD	Eu Ivd General	On Market
BLOOD GAS CALIBRATORS AND STANDARDS ELECTRODES OR CASSETTE	EU IVDD	Eu Ivd General	On Market
BLOOD GAS CONTROLS -ELECTRODES OR CASSETTE	EU IVDD	Eu Ivd General	On Market
C-REACTIVE PROTEIN	EU IVDD	Eu Ivd General	On Market
CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)	EU IVDR	Eu Ivd Class A	Not EU
CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)	EU IVDR	Eu Ivd Class A	Not EU
ELECTROLYTE CONTROLS	EU IVDD	Eu Ivd General	On Market
Electrolyte Analyzer	EU IVDR	Eu Ivd Class A	On Market
Glycated Hemoglobin Analyzer	EU IVDD	Eu Ivd General	On Market
Glycated Hemoglobin Analyzer	EU IVDD	Eu Ivd General	On Market
HAEMOGLOBIN CONTROLS	EU IVDD	Eu Ivd General	On Market
Hematology Analyzer	EU IVDR	Eu Ivd Class A	On Market
RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER	EU IVDD	Eu Ivd General	On Market
VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER	EU IVDR	Eu Ivd Class A	On Market