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Fluorescence Immunoassay Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983155052
Basic UDI-DI: 6970277510004YZ7
Reference: AFR-101
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

FloQuant™ Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459007032
Basic UDI-DI: 8905459FLOQB3
Reference: SAAFIA-02
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

FloQuant™ Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459007049
Basic UDI-DI: 8905459FLOQB3
Reference: SAAFIA-03
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View details

06941967242291

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242291
Basic UDI-DI: 6973262860014626
Reference: 0112805
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

EXR 120

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200208
Basic UDI-DI: 69732628600036ZT
Reference: 02-11-03-0005-00
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View 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 products View 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

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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 products View 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 products View details

Lateral Flow (LF) Portable Reader Plus

IVD generalNot specifiedOn the market

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983131278
Basic UDI-DI: B-06936983131278
Reference: ATR-400
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 24.06.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow (LF) Reader

IVD generalNot specifiedOn the market

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983107945
Basic UDI-DI: B-06936983107945
Reference: ATR-001
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.06.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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 products Authorised representative products Authorised representative actors View 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: 06936415977627
Basic UDI-DI: 69449040MYYQ-BM6M******TG
Reference: CL-6200i
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 products Authorised representative products Authorised representative actors View 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: 06936415977610
Basic UDI-DI: 69449040MYYQ-BM10******9M
Reference: CL-2200i
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 products Authorised representative products Authorised representative actors View 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: 06936415902605
Basic UDI-DI: 69449040MYYQ-BM50******BZ
Reference: CL-900i
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 16:23

Manufacturer products Authorised representative products Authorised representative actors View details