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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

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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

Chemiluminescence Immunoassay Analyzer

Shine i3920

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140171177
Basic UDI-DI: 697514017Shinei3920HF
Reference: Shine i3920
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 i6910

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140171146
Basic UDI-DI: 697514017Shinei6910HZ
Reference: Shine i6910
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 i16900

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140171016
Basic UDI-DI: 697514017Shinei6900HW
Reference: Shine i6900
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 i9910

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170903
Basic UDI-DI: 697514017Shinei9910JN
Reference: GS1
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: 02.07.2026 18:15

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

Shine i8900

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Shenzhen Increcare Biotech Co., Ltd
Manufacturer SRN: CN-MF-000027299
UDI-DI: 06975140170811
Basic UDI-DI: 697514017Shinei8900JC
Reference: GS1
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: 02.07.2026 18:15

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