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Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301677
Basic UDI-DI: 6936895BS0172H
Reference: BS017
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300298
Basic UDI-DI: 6936895BS00326
Reference: BS003
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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Electrolyte Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300250
Basic UDI-DI: 6936895BS0062C
Reference: BS006
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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Elisa Microplate Reader

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300212
Basic UDI-DI: 6936895BS0052A
Reference: BS005
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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Semi-auto Chemistry Analyzer

Biobase-Silver

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300151
Basic UDI-DI: 6936895BS00224
Reference: BS002
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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FIA Analyzer FLI-100

FLI-100

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209064
Basic UDI-DI: 69332602IT01000029T
Reference: BT0106
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

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FIA Analyzer BIOT-YG-I

BIOT-YG-I

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260209088
Basic UDI-DI: 69332602IT01000049X
Reference: BT0104
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

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Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010691
Basic UDI-DI: 6934175001A0620P3
Reference: 7C002
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

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Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010707
Basic UDI-DI: 6934175001A0620P3
Reference: 7C003
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

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Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010714
Basic UDI-DI: 6934175001A0620P3
Reference: 7C004
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

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Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026067
Basic UDI-DI: 6934175001A0620P3
Reference: 7D001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

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06926980316945

Kaeser 8800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980316945
Basic UDI-DI: 69269803YQKaeser8800XH
Reference: CK-KR-CLIA-008
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 18:42

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06926980316938

Kaeser 6800plus

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980316938
Basic UDI-DI: 69269803YQKaeser6800X3
Reference: CK-KR-CLIA-007
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 18:42

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06926980316891

Kaeser 2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980316891
Basic UDI-DI: 69269803YQKaeser2000UX
Reference: CK-KR-CLIA-001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

HiLIA 1250i

HiLIA 1250i, HiLIA 1251i, HiLIA 1252i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Kangrun Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032267
UDI-DI: 06926980315368
Basic UDI-DI: 69269803YQHiLIA1250i3F
Reference: CK-KR-BLOT-005
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

06926802608869

Immu F200C, Immu F220C, Immu F200L, Immu F220L, Immu F400L, Immu F600L

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802608869
Basic UDI-DI: 69268026ImmuF200C000001RF
Reference: Immu F200C
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescence Immunoassay Analyzer

Immu F6, Immu F6S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802602737
Basic UDI-DI: 69268026ImmuF60001KS
Reference: Immu F6
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

06925912734864

Tenfly Phoenix-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912734864
Basic UDI-DI: 692591270283HR
Reference: T0247
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

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06925912734451

iBC 900-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912734451
Basic UDI-DI: 692591270282HP
Reference: BC0204
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

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06925912715245

iFlash 9000-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715245
Basic UDI-DI: 692591270180HE
Reference: FG0076
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:34

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