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Last updated

22.09.2026 04:18

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3478196

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Active filter:EMDN:W0201020102

151 device results listed.

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06973864380523

LiCA Smart

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing
Manufacturer
Chemclin Diagnostics Co., Ltd.
Manufacturer SRN
CN-MF-000009729
UDI-DI
06973864380523
Basic UDI-DI
6973864380104EH
Reference
04090113000
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Czechia
Authorised representative
MedNet EC-REP GmbH
Last updated
21.09.2026 21:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06921893001728

NORMAN-CL211A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN
CN-MF-000024233
UDI-DI
06921893001728
Basic UDI-DI
69218930057106Z
Reference
12000003000
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Bulgaria
Authorised representative
Sungo Cert GmbH
Last updated
11.08.2026 13:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06921893001711

NORMAN-CL211,NRM411-S7

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN
CN-MF-000024233
UDI-DI
06921893001711
Basic UDI-DI
69218930057067A
Reference
12000001500
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Bulgaria
Authorised representative
Sungo Cert GmbH
Last updated
11.08.2026 13:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Fully automatic chemiluminescence immunoassay analyzer

AI-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000045346
UDI-DI
06974576208587
Basic UDI-DI
697457620SSFaciaMP
Reference
2FF00001
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Romania
Authorised representative
Medunion S.L.
Last updated
07.08.2026 02:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PLab (Personal LAB)

Personal LAB

IVD generalIVDDOn the marketInstrumentProfessional testing
Manufacturer
ADALTIS SRL
Manufacturer SRN
IT-MF-000028990
UDI-DI
++M521PL01DZ
Basic UDI-DI
B-++M521PL01DZ
Reference
PL-01
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Czechia
Authorised representative
-
Last updated
04.08.2026 23:02
Manufacturer productsView details
Atellica IM 1300 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414650579
Basic UDI-DI
0405686901508VK
Reference
11764765
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Belgium
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
04.08.2026 20:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay 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
06903053038829
Basic UDI-DI
69449040MYYQ-BM10******9M
Reference
CLIA 2000
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay 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
06903053037372
Basic UDI-DI
69449040MYYQ-BM50******BZ
Reference
CLIA 900
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay 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
06903053033800
Basic UDI-DI
69449040MYYQ-BM20******A8
Reference
CLIA 1000
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay Analyzer

CL-2600i、CL-2800i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053033787
Basic UDI-DI
69449040AB4000002ZW
Reference
CL-2600i
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06926980316891

Kaeser 2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000032267
UDI-DI
06926980316891
Basic UDI-DI
69269803YQKaeser2000UX
Reference
CK-KR-CLIA-001
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Austria
Authorised representative
Sungo Cert GmbH
Last updated
31.07.2026 18:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06926802608869

Immu F200C, Immu F220C, Immu F200L, Immu F220L, Immu F400L, Immu F600L

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN
CN-MF-000005925
UDI-DI
06926802608869
Basic UDI-DI
69268026ImmuF200C000001RF
Reference
Immu F200C
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Netherlands
Authorised representative
R Sight B.V.
Last updated
31.07.2026 18:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06925912715276

iFlash 1200-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912715276
Basic UDI-DI
692591270115H3
Reference
FG0074
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Cyprus
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06925912710585

iFlash 1800-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912710585
Basic UDI-DI
692591270142H6
Reference
C6104
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Greece
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CM-180 Chemiluminescence Immunoassay Analyzer

CM-180

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN
CN-MF-000001891
UDI-DI
06925794515025
Basic UDI-DI
69257945W0201020102D0K5
Reference
3015506
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Romania
Authorised representative
SUNGO Europe B.V.
Last updated
31.07.2026 18:27
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay Analyzer

Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000001096
UDI-DI
06921963722959
Basic UDI-DI
692196372293JG
Reference
BOSON 3000
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
31.07.2026 18:12
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800

LEPU Quant 800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use
Manufacturer
BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN
CN-MF-000033011
UDI-DI
06921807601136
Basic UDI-DI
692180760113EM
Reference
JY04LEPU Quant 800
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
France
Authorised representative
Lepu Medical (Europe) Cooperatief U.A.
Last updated
31.07.2026 18:11
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Optilite® Analyser

IE700

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
The Binding Site Group Ltd
Manufacturer SRN
UK-MF-000036707
UDI-DI
05051700020893
Basic UDI-DI
5051700IE700F9
Reference
IE700
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Germany
Authorised representative
The Binding Site Ireland Limited
Last updated
31.07.2026 08:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
04987562429981

Automated Immunoassay System HISCL-5000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
SYSMEX CORPORATION
Manufacturer SRN
JP-MF-000014037
UDI-DI
04987562429981
Basic UDI-DI
4987562HISCL-5000X8
Reference
AF022051
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Germany
Authorised representative
Sysmex Europe SE
Last updated
31.07.2026 07:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HM-CODIAM

HM-CODIAM

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing
Manufacturer
Canon Medical Diagnostics Corporation
Manufacturer SRN
JP-MF-000020364
UDI-DI
04987295660903
Basic UDI-DI
4987295BU00422
Reference
66090
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Spain
Authorised representative
Obelis s.a.
Last updated
31.07.2026 07:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details