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146 device results listed.

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Sphera

Sphera - Automated Immunochemistry Analyser

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Edif Instruments S.r.l.
Manufacturer SRN: IT-MF-000009556
UDI-DI: 80536089400722
Basic UDI-DI: 805360894ES000014T
Reference: ES00001-B
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:56

Manufacturer products View details

DIA500

DP5

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616042729
Basic UDI-DI: 805061604INE57M
Reference: DP5
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Bulgaria
Authorised representative: -
Last updated: 03.07.2026 08:39

Manufacturer products View details

Eu-Turbo Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169208053
Basic UDI-DI: 802816920AW02010608012J
Reference: 9194
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:39

Manufacturer products View details

cobas e 402 analytical unit

cobas pure integrated solutions

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336172506
Basic UDI-DI: 761333601773BA
Reference: 09031553001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

Phadia 1000

Phadia Instruments

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066001005
Basic UDI-DI: 7333066BUDI0015LT
Reference: 12-3800-01
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

Automatic Chemiluminescence lmmunoanalyzer

AI 2600, AI 2610, AI 2620, AI 2660, AI 2680

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: 06978151200096
Basic UDI-DI: 697815120CLIAAI2600Q3
Reference: AI 2600, AI 2610, AI 2620, AI 2660, AI 2680
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated Fecal Immunochemical Test Analyzer

FIT-1000/1200/1600/1800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Cavan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000052933
UDI-DI: 06977568200019
Basic UDI-DI: 697756820FIT-EQSV
Reference: FIT-1000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

Shine i1920

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170644
Basic UDI-DI: 697514017Shinei1920GZ
Reference: GS1
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170569

shine i2930

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170569
Basic UDI-DI: 697514017SHINE-i29303V
Reference: GS1
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170484

shine i2920

IVD Class AIVDR 2017/746On the marketInstrumentKit

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170484
Basic UDI-DI: 697514017SHINE-i29203S
Reference: GS1
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170408

shine i1910

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170408
Basic UDI-DI: 697514017YK-SHINE-I1910UL
Reference: 06975140170408
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

Shine i1110

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170347
Basic UDI-DI: 697514017Shinei1110FN
Reference: GS1
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170323

shine i1900

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170323
Basic UDI-DI: 697514017YK-SHINE-I1900UH
Reference: 06975140170323
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170248

Shine i2910

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170248
Basic UDI-DI: 697514017shine-i29108D
Reference: GS1
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170187

Shine i2110

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170187
Basic UDI-DI: 697514017Shinei2110FV
Reference: GS1
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975140170064

shine i2900

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170064
Basic UDI-DI: 697514017YK-SH-IRD
Reference: 06975140170064
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Electrochemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: 06974795529999
Basic UDI-DI: 697479552SECAUL
Reference: SECA
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: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Electrochemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: 06974795529982
Basic UDI-DI: 697479552SEBAUH
Reference: SEBA
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: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

GBI-MAP 800Plus

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan BGI Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019026
UDI-DI: 06974742360064
Basic UDI-DI: 697474236006M2
Reference: GBI-MAP 800Plus
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: 02.07.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

MAE-1200i

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan BGI Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019026
UDI-DI: 06974742360033
Basic UDI-DI: 697474236003LU
Reference: MAE-1200i
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: 02.07.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details