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08800037900005

SimplexTAS 101 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900005
Basic UDI-DI: 880003790000AV
Reference: T0001001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

COPROSS

C100Y

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147122614
Basic UDI-DI: 8606014712261YW
Reference: C100Y
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 17:09

Manufacturer products Authorised representative products Authorised representative actors View details

JUNO Automatic eCLIA Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287397055
Basic UDI-DI: 843528739705JG
Reference: 7700010
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:59

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Aura POCT CLIA Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287397000
Basic UDI-DI: 843528739700J6
Reference: 7700000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:59

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KROMA Plus iT Automatic Immunological Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393309
Basic UDI-DI: 843528739330HT
Reference: 3800070
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

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KROMA iT Automatic Immunological Analyzer

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 8435287393101
Basic UDI-DI: 843528739310HM
Reference: 3800050
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:58

Manufacturer products View details

Aptiva® Multi-Analyte Instrument

AP5000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426951307227
Basic UDI-DI: 84269513072276Z
Reference: AP5000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:14

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CHORUS EVO

CHORUSEVO

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322670
Basic UDI-DI: 803389132CHORUSEVO009X
Reference: 82000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:18

Manufacturer products View details

cobas e 411 analyzer (disk system)

cobas e 411 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630937103
Basic UDI-DI: 761333601321A3
Reference: 04775201001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

cobas e 411 analyzer (rack system)

cobas e 411 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630924721
Basic UDI-DI: 7613336013209Z
Reference: 04775279001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

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Fully Automated Chemiluminescence Immunoassay Analyzer

SC200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020419
Basic UDI-DI: 6978848020419HK
Reference: A00816000EN0
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

06978465230192

Bright i60 Series (including Bright i30, Bright i36, Bright i38, Bright i39,Bright i60, Bright i66, Bright i68, Bright i69 models); Bright i100 Series (includingBright i100, Bright i160, Bright i180, Bright i190 models); etc

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230192
Basic UDI-DI: 697846523FACIAN3
Reference: Bright i60 Series Bright i30
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

06978189070005

JIE-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189070005
Basic UDI-DI: 697818907JZMIAY5
Reference: JIE-200
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90

AST-Dx90

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Astrabio Technology Co., Ltd.
Manufacturer SRN: CN-MF-000041763
UDI-DI: 06977100860091
Basic UDI-DI: 697710086ASTMYN9
Reference: 8901000100
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

Cyclic Enhanced Fluorescence Analyzer

Pylon 3D

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentKitProfessional testing

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485020038
Basic UDI-DI: 697648502P3DU3
Reference: 41-2008
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Fluorescence Immunoassay Analyzer

BKP500, BKP600, etc.

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750534
Basic UDI-DI: 69763747505BKP****RT
Reference: BKP500
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

BKP1000，BKP2000, BKP3000

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: BIOBASE POCT CO.,LTD
Manufacturer SRN: CN-MF-000045945
UDI-DI: 06976374750503
Basic UDI-DI: 697637475052B
Reference: BKP1000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

ICL-6E, ICL-12E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Render Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032470
UDI-DI: 06976033400039
Basic UDI-DI: 697603340CE0016U
Reference: CE001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Venus 120S

Venus 100S,Venus 120S,Venus 100H,Venus 120H,BioCLIA 1900,Venus 500,VERCENTRA CS-6000,BioCLIA 6900

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Keylights Biotechnology (Chongqing) Co.,Ltd.
Manufacturer SRN: CN-MF-000033853
UDI-DI: 06975879670019
Basic UDI-DI: 697587967KLS00019Q
Reference: KLSXXXXXX
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:15

Manufacturer products Authorised representative products Authorised representative actors View details

06975838807555

MI200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838807555
Basic UDI-DI: 697583880MI003NN
Reference: HE10016
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details