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Bio 30+ Sys Physio HP EZ Nin

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Biochrom Ltd
Manufacturer SRN: GB-MF-000025158
UDI-DI: 05056336800239
Basic UDI-DI: 50563368AAAIVDSC0013Q
Reference: 80-6000-53EZ
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 19:35

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Bio 30+ Physio W/O A/S HP

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Biochrom Ltd
Manufacturer SRN: GB-MF-000025158
UDI-DI: 05056336800253
Basic UDI-DI: 50563368AAAIVDSC0013Q
Reference: 80-6000-55
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 19:35

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Bio 30+ System Physio HR

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Biochrom Ltd
Manufacturer SRN: GB-MF-000025158
UDI-DI: 05056336800260
Basic UDI-DI: 50563368AAAIVDSC0013Q
Reference: 80-6000-56
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 19:35

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Bio 30+ Physiological HR

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Biochrom Ltd
Manufacturer SRN: GB-MF-000025158
UDI-DI: 05056336800277
Basic UDI-DI: 50563368AAAIVDSC0013Q
Reference: 80-6000-57
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 19:35

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Bio 30+ Physio W/O A/S HR

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Biochrom Ltd
Manufacturer SRN: GB-MF-000025158
UDI-DI: 05056336800284
Basic UDI-DI: 50563368AAAIVDSC0013Q
Reference: 80-6000-58
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 19:35

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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: 06936895302698
Basic UDI-DI: 6936895BS00326
Reference: BK-410
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 19:27

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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: 06936895302681
Basic UDI-DI: 6936895BS00326
Reference: BK-310
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 19:17

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Blood Glucose Meter

G-427B,G-425-2

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentSelf testing

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184631516
Basic UDI-DI: 6939184630001BD
Reference: G-427B
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Malta
Safety summary (SSCP/SSP): IVDR-BL-BGMS-21 · Rev. A4
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:11

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05070002421320

Dxcover Control Pack

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421320
Basic UDI-DI: 50700024213ControlsZB
Reference: DXC-CP-001
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 19:05

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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: 06936895300304
Basic UDI-DI: 6936895BS00326
Reference: BS003
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:04

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Sinocare

H102 Air ，H101

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010684
Basic UDI-DI: 6934175001A0620P3
Reference: 7C001
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

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Automatic chemistry analyzer

Spin XS， Spin XL ， Spin XT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302841
Basic UDI-DI: 69368953028ACA-Spin**38
Reference: Spin XL
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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Elisa Plate Reader

DIA2000

IVD Class AIVDR 2017/746On the marketAnimal tissuesInstrumentMicrobial substancesProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302438
Basic UDI-DI: 6936895BS0182K
Reference: BS018
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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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details