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Urine Analyzer

Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983107457
Basic UDI-DI: 6970277510002QYH
Reference: AUR-100
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983107440
Basic UDI-DI: 6970277510002VYT
Reference: ACIR-100
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow (LF) Reader Plus

Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983105712
Basic UDI-DI: 6970277510002UYR
Reference: ATR-300
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06936983104227

Cup Reader

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104227
Basic UDI-DI: 6970277510002RYK
Reference: ACR-100
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600152

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600152
Basic UDI-DI: 695441761106R32K
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600145

M3 Pro

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600145
Basic UDI-DI: 695441761106R42M
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600138

NOVEOS X

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600138
Basic UDI-DI: 695441761106R72T
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

CI 1200 Automated Chemiluminescence Immunoassay Analyzer

CI 1200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005180
Basic UDI-DI: 69543760Y00001DJ
Reference: 69543760Y00001DJ
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

CI 2000S Automated Chemiluminescence Immunoassay Analyzer

CI 2000S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005173
Basic UDI-DI: 69543760Y00002DL
Reference: 69543760Y00001DJ
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

06952804825645

Fully Automatic Chemiluminescence analyzer

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825645
Basic UDI-DI: 69528048CLI1000XN4
Reference: CLI1000X
EMDN: W0201010280
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

06950191080128

EUROLineCamera

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Euroimmun (Hangzhou) Medical Laboratory Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000029679
UDI-DI: 06950191080128
Basic UDI-DI: 69501910ELC00018U
Reference: CYQ-BL-ELCS-10-0102
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: EUROIMMUN Medizinische Labordiagnostika AG
Last updated: 31.07.2026 20:18

Manufacturer products Authorised representative products Authorised representative actors View details

06950191080043

EUROLineMaster II

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Euroimmun (Hangzhou) Medical Laboratory Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000029679
UDI-DI: 06950191080043
Basic UDI-DI: 69501910ELMII00012X
Reference: CYQ-BL-ELM-20-2050
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: EUROIMMUN Medizinische Labordiagnostika AG
Last updated: 31.07.2026 20:18

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

BC400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040103363
Basic UDI-DI: 69450401BC400AS
Reference: BC400
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:03

Manufacturer products Authorised representative products Authorised representative actors View details

Semi-auto Biochemistry Analyzer

BC300

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040103356
Basic UDI-DI: 69450401BC300AM
Reference: BC300
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: France
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:03

Manufacturer products Authorised representative products Authorised representative actors View details

Urine analyzer

BC401

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040101369
Basic UDI-DI: 69450401BC401AU
Reference: BC401
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:03

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904091570
Basic UDI-DI: 69449040XQYQ-3208CRP1**KN
Reference: CRP-M100
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904084466
Basic UDI-DI: 69449040SHYQ-BA81******PK
Reference: BA-800M
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037998
Basic UDI-DI: 69449040SHYQ-BA2M******2F
Reference: BS-2000M
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904018676
Basic UDI-DI: 69449040SHYQ-BA20******KG
Reference: BS-200
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details

Semi-auto Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904017631
Basic UDI-DI: 69449040SHYQ-BA89******TT
Reference: BA-88A
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:59

Manufacturer products Authorised representative products Authorised representative actors View details