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Last updated

03.08.2026 18:01

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2994157

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Active filter:EMDN:W02010201

750 device results listed.

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Chemiluminescence Analyzer

Lumiray 1600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
06947024409713
Basic UDI-DI
69470244013665Y
Reference
Lumiray 1600
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 00:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Analyzer

Lumiray 1200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
06947024409706
Basic UDI-DI
694702440135963
Reference
Lumiray 1200
EMDN
W0201020102
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 00:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Analyzer

Lumiray 680

IVD Class AIVDR 2017/746On the marketDirect markingInstrument
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
06947024409690
Basic UDI-DI
694702440219666
Reference
Lumiray 680
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 00:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Analyzer

Lumiray 630

IVD Class AIVDR 2017/746On the marketDirect markingInstrument
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
06947024409683
Basic UDI-DI
69470244021655T
Reference
Lumiray 630
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 00:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Analyzer

Lumiray 600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
06947024409676
Basic UDI-DI
69470244021415D
Reference
Lumiray 600
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 00:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Agnitio BioIC Analyzer

-

IVD Class ANot specifiedOn the marketDirect marking
Manufacturer
AGNITIO SCIENCE &TECHNOLOGY,INC.
Manufacturer SRN
TW-MF-000040942
UDI-DI
04719892999021
Basic UDI-DI
471989299Analyzer8A
Reference
BA-G2012 series
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
26.06.2026 15:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Agnitio BioIC Analyzer

-

IVD Class ANot specifiedNot intended for EU marketDirect marking
Manufacturer
AGNITIO SCIENCE &TECHNOLOGY,INC.
Manufacturer SRN
TW-MF-000040942
UDI-DI
04719892999052
Basic UDI-DI
471989299Analyzer8A
Reference
BA400 series
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
26.06.2026 15:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Agnitio BioIC Analyzer

-

IVD Class ANot specifiedNot intended for EU marketDirect marking
Manufacturer
AGNITIO SCIENCE &TECHNOLOGY,INC.
Manufacturer SRN
TW-MF-000040942
UDI-DI
04719892999069
Basic UDI-DI
471989299Analyzer8A
Reference
BA2400 series
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
26.06.2026 15:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Agnitio BioIC Analyzer

-

IVD Class ANot specifiedNot intended for EU marketDirect marking
Manufacturer
AGNITIO SCIENCE &TECHNOLOGY,INC.
Manufacturer SRN
TW-MF-000040942
UDI-DI
04719892999076
Basic UDI-DI
471989299Analyzer8A
Reference
BA1200 series
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
26.06.2026 15:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
FREND 2.0

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
NanoEntek, Inc.
Manufacturer SRN
KR-MF-000021903
UDI-DI
08809317541259
Basic UDI-DI
880931754FRENDKQ
Reference
F20
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
-
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
26.06.2026 02:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BlueDiver

-

IVD Class ANot specifiedOn the marketDirect marking
Manufacturer
D-tek s.a.
Manufacturer SRN
BE-MF-000024530
UDI-DI
05425023685051
Basic UDI-DI
5425023685006VX
Reference
AD INSTRUMENT
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Belgium
Authorised representative
-
Last updated
25.06.2026 17:23
Manufacturer productsView details
BlueDiver Scanner/DR DOT Software Licence

-

IVD Class ANot specifiedOn the marketDirect marking
Manufacturer
D-tek s.a.
Manufacturer SRN
BE-MF-000024530
UDI-DI
05425023685068
Basic UDI-DI
5425023685013VU
Reference
AD SCANBD + AD SOFTBD
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Belgium
Authorised representative
-
Last updated
25.06.2026 17:23
Manufacturer productsView details
Neptune Instrument

-

IVD Class ANot specifiedOn the marketDirect marking
Manufacturer
D-tek s.a.
Manufacturer SRN
BE-MF-000024530
UDI-DI
05425023685082
Basic UDI-DI
5425023685006VX
Reference
DIA1000
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Belgium
Authorised representative
-
Last updated
25.06.2026 17:23
Manufacturer productsView details
Neptune Scanner/Neptune Software

-

IVD Class ANot specifiedOn the marketDirect marking
Manufacturer
D-tek s.a.
Manufacturer SRN
BE-MF-000024530
UDI-DI
05425023685099
Basic UDI-DI
5425023685013VU
Reference
DIA1003 + DIA1001
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
Belgium
Authorised representative
-
Last updated
25.06.2026 17:23
Manufacturer productsView details
Chemiluminescence Immunoassay Analyzer

-

IVD Class ANot specifiedOn the market
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06936415977696
Basic UDI-DI
69449040MYYQ-BM50******BZ
Reference
CL-980i
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
24.06.2026 16:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay Analyzer

-

IVD Class ANot specifiedOn the market
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06936415977689
Basic UDI-DI
69449040MYYQ-BM50******BZ
Reference
CL-960i
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
24.06.2026 16:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay Analyzer

-

IVD Class ANot specifiedOn the market
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06936415977672
Basic UDI-DI
69449040MYYQ-BM50******BZ
Reference
CL-920i
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
24.06.2026 16:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemiluminescence Immunoassay Analyzer

-

IVD Class ANot specifiedOn the market
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06936415977665
Basic UDI-DI
69449040AB400000629
Reference
CL-9200i
EMDN
W0201020104
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
24.06.2026 16:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06936415977641

-

IVD Class ANot specifiedOn the market
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06936415977641
Basic UDI-DI
69449040MYYQ-BM60*****FM
Reference
CL-8200i
EMDN
W0201020104
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
24.06.2026 16:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details