Yantai Addcare Bio-Tech Co.,Ltd.

SRN: CN-MF-000018409 · Nanjing Street No.10, 265501 Yantai, China

View on EUDAMED

Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Nanjing Street No.10, 265501 Yantai, China
Email: [email protected]
Website: www.addcare.cn

Regulatory Overview

Regulation

Eu Ivdr 20

Classification

Eu Ivd Class A 20

Device Types

Certificate Health

No certificates registered for this manufacturer.

Device Portfolio

Name	Regulation	Classification	Market Status
AUTOMATED BLOOD GROUPING ANALYSERS	EU IVDR	Eu Ivd Class A	Not EU
AUTOMATED BLOOD GROUPING ANALYSERS	EU IVDR	Eu Ivd Class A	Not EU
AUTOMATED BLOOD GROUPING ANALYSERS	EU IVDR	Eu Ivd Class A	Not EU
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)	EU IVDR	Eu Ivd Class A	Not EU
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)	EU IVDR	Eu Ivd Class A	On Market
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)	EU IVDR	Eu Ivd Class A	Not EU
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)	EU IVDR	Eu Ivd Class A	On Market
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)	EU IVDR	Eu Ivd Class A	Not EU
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)	EU IVDR	Eu Ivd Class A	On Market
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)	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	Not EU
IMMUNOCHEMISTRY READERS	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	Not EU
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER	EU IVDR	Eu Ivd Class A	On Market
ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER	EU IVDR	Eu Ivd Class A	On Market
ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER	EU IVDR	Eu Ivd Class A	On Market
ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER	EU IVDR	Eu Ivd Class A	On Market