- Manufacturer
- Aikang MedTech Co., Ltd
- Manufacturer SRN
- CN-MF-000027272
- UDI-DI
- 06974621212392
- Basic UDI-DI
- 697462121C900C5
- Reference
- C 900
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 02.07.2026 17:04
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
25.09.2026 07:34
Sync status
Successful
Device
3654057
Actor
47908
Certificate
3410
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Chemiluminescence Immunoassay Analyzer
CLIA-mate Series
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Aikang MedTech Co., Ltd
- Manufacturer SRN
- CN-MF-000027272
- UDI-DI
- 06974621212118
- Basic UDI-DI
- 697462121CLIAmateGJ
- Reference
- CLIA-mate
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 02.07.2026 17:04
Fluorescent Immunoanalyzer
YFA 100
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Aikang MedTech Co., Ltd
- Manufacturer SRN
- CN-MF-000027272
- UDI-DI
- 06974621212101
- Basic UDI-DI
- 697462121YFA100FJ
- Reference
- YFA 100
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 02.07.2026 17:04
06974621211722
URANUS AE Series
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Aikang MedTech Co., Ltd
- Manufacturer SRN
- CN-MF-000027272
- UDI-DI
- 06974621211722
- Basic UDI-DI
- 697462121URANUSAEL3
- Reference
- URANUS AE 55
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 02.07.2026 17:04
Automated Chemiluminescence Immunoassay Analyzer
Lumimate 300A
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Aikang MedTech Co., Ltd
- Manufacturer SRN
- CN-MF-000027272
- UDI-DI
- 06974621211579
- Basic UDI-DI
- 697462121LumimateZQ
- Reference
- Lumimate 300A
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 02.07.2026 17:04
Uni-medica Fluorescent Immunoanalyzer
Automatic Nucleic Acid System
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Shenzhen Uni-medica Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000022946
- UDI-DI
- 06974561521332
- Basic UDI-DI
- 697456152UM-IF1003K
- Reference
- UM-IF 100
- EMDN
- W0201020201
- EMDN description
- IMMUNOCHEMISTRY READERS
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 16:29
HC-10 Portable Colloidal Gold Immunoassay Analyzer
HC-10 Portable Colloidal Gold Immunoassay Analyzer
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Nanjing Synthgene Medical Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000023810
- UDI-DI
- 06974473303712
- Basic UDI-DI
- 697447330HC10HD
- Reference
- HC10
- EMDN
- W0201020280
- EMDN description
- LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
- First on market country
- Germany
- Authorised representative
- MedPath GmbH
- Last updated
- 02.07.2026 16:16
Colloidal Gold Reader
GIA100
IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing
- Manufacturer
- Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000024153
- UDI-DI
- 06974404980043
- Basic UDI-DI
- 697440498gia3A
- Reference
- GIA100
- EMDN
- W0201020201
- EMDN description
- IMMUNOCHEMISTRY READERS
- First on market country
- -
- Authorised representative
- QbD RepS BV
- Last updated
- 02.07.2026 15:57
Automatic Chemiluminescence Immunoassay Analyzer
VERCENTRA CS-1500, VERCENTRA CS-3000
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Virtue Diagnostics (Suzhou) Co., Ltd
- Manufacturer SRN
- CN-MF-000013251
- UDI-DI
- 06974402559012
- Basic UDI-DI
- 697440255INST_VIRTUOSO6E
- Reference
- 11000002
- EMDN
- W0201020102
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
- First on market country
- Netherlands
- Authorised representative
- Kingsmead Service B.V.
- Last updated
- 02.07.2026 15:57
Fully Automatic ELISA Analyzer
ME-1000、ME-2000Pro、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro、 ME-8800、ME-8800D、ME-8800DPlus、ME-8800DPro、ME-8800L、ME-8800LPlus、ME-8800LPro etc.
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Changsha Imadek Intelligent Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000042852
- UDI-DI
- 06974312710008
- Basic UDI-DI
- 697431271MEYU
- Reference
- ME-1000
- EMDN
- W02010299
- EMDN description
- IMMUNOCHEMISTRY INSTRUMENTS - OTHER
- First on market country
- Germany
- Authorised representative
- Sungo Cert GmbH
- Last updated
- 02.07.2026 15:50
POCLia8
Chemiluminescence Immunoassay Analyzer
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Taizhou Zecen Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000050486
- UDI-DI
- 06974201150762
- Basic UDI-DI
- 697420115YQ001DZ
- Reference
- Chemiluminescence Immunoassay Analyzer
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- France
- Authorised representative
- MedPath GmbH
- Last updated
- 02.07.2026 15:39
Automated Chemiluminescent Immunoassay Analyzing System
MS-Fast pro 240
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Sophonix Co., Ltd.
- Manufacturer SRN
- CN-MF-000021894
- UDI-DI
- 06974183540872
- Basic UDI-DI
- 697418354A07NT
- Reference
- A07
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Poland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 15:38
Automated Chemiluminescent Immunoassay Analyzing System
MS-Fast pro 160
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Sophonix Co., Ltd.
- Manufacturer SRN
- CN-MF-000021894
- UDI-DI
- 06974183540865
- Basic UDI-DI
- 697418354A06NR
- Reference
- A06
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Poland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 15:38
Automated Chemiluminescent Immunoassay Analyzing System
MS-Fast pro 80
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Sophonix Co., Ltd.
- Manufacturer SRN
- CN-MF-000021894
- UDI-DI
- 06974183540841
- Basic UDI-DI
- 697418354A05NP
- Reference
- A05
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Poland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 15:37
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Sophonix Co., Ltd.
- Manufacturer SRN
- CN-MF-000021894
- UDI-DI
- 06974183540834
- Basic UDI-DI
- 697418354A08NV
- Reference
- A08
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Poland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 15:37
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Sophonix Co., Ltd.
- Manufacturer SRN
- CN-MF-000021894
- UDI-DI
- 06974183540292
- Basic UDI-DI
- 697418354A02NH
- Reference
- A02
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Poland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 15:37
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Sophonix Co., Ltd.
- Manufacturer SRN
- CN-MF-000021894
- UDI-DI
- 06974183540216
- Basic UDI-DI
- 697418354A01NF
- Reference
- A01
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Poland
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 15:37
Fluorescence Immunoassay Analyzer
FluoreMini
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- SINGUWAY BIOTECH INC.
- Manufacturer SRN
- CN-MF-000027180
- UDI-DI
- 06974081870736
- Basic UDI-DI
- 697408187FluoreMiniL4
- Reference
- FluoreMini
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Greece
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 02.07.2026 15:26
06974071231059
Palm F
IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
- Manufacturer
- Shijiazhuang Hipro Biotechnology Co.,Ltd
- Manufacturer SRN
- CN-MF-000002171
- UDI-DI
- 06974071231059
- Basic UDI-DI
- 697407123PalmFX4
- Reference
- Palm F
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Germany
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 02.07.2026 15:24
06974071231011
HP-AFS/1
IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
- Manufacturer
- Shijiazhuang Hipro Biotechnology Co.,Ltd
- Manufacturer SRN
- CN-MF-000002171
- UDI-DI
- 06974071231011
- Basic UDI-DI
- 697407123HP-AFS/1QG
- Reference
- HP-AFS/1
- EMDN
- W0201020101
- EMDN description
- AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- First on market country
- Germany
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 02.07.2026 15:24