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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 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

UniCel DxI 600 Access Immunoassay System

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590341602
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A30260
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

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UniCel DxI 800 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590369194
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A71456
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

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UniCel DxI 600 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590369224
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A71460
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

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

06975569870132

CLS60

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen Sinseng Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000024231
UDI-DI: 06975569870132
Basic UDI-DI: 697556987CLS60UF
Reference: CLS60
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumilite8

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06975292640026
Basic UDI-DI: 697529264002MS
Reference: 102
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

Professional testing

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSelf testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06975292640019
Basic UDI-DI: 697529264001MQ
Reference: 101
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Türkiye
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

Shine i3910

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140171191
Basic UDI-DI: 697514017Shinei3910HC
Reference: Shine i3910
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 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 i3900

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140171184
Basic UDI-DI: 697514017Shinei3900H9
Reference: Shine i3900
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 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