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AutoChem Wash C

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253020678
Basic UDI-DI: 69422530000129NT
Reference: 360115XYC0001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:31

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AutoChem Wash B

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253020630
Basic UDI-DI: 69422530000128NR
Reference: 360115XYB0001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:31

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AutoChem Wash A

Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253020593
Basic UDI-DI: 69422530000127NP
Reference: 360115XYA0001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem HBDH

AutoChem analyzer

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253005941
Basic UDI-DI: 69422530000062NL
Reference: 360105HBD000S
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

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AutoChem GLU

AutoChem series instrument

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253004661
Basic UDI-DI: 69422530000049NU
Reference: 360104GLU000S
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

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AutoChem β2-MG

AutoChem analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253002940
Basic UDI-DI: 69422530000031N9
Reference: 360102BMG000V
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

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AutoChem UA

AutoChem series instrument

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253002469
Basic UDI-DI: 69422530000026NG
Reference: 360102UA0000S
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

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Determinand Cleaning Liquid

150mL/bottle, 500mL/bottle, 4×500mL/bottle

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226625
Basic UDI-DI: 69422022W010106029901R0EG
Reference: 3024590
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:29

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Linksun Blood Glucose Monitoring System

G-427B/G-427BS,G-425-2/G-425-2S,G-425-1/G-425S-1,G-426/G-425S-1,G-430/G-425S-1

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitReagentSelf testingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184631486
Basic UDI-DI: 6939184630021BK
Reference: G-425-1/G-425S-1
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
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

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Glucose Test Strips

G-427BS,G-425-2S,G-425S-1

IVD Class CIVDR 2017/746On the marketDirect markingSelf testingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184601007
Basic UDI-DI: 6939184600001AC
Reference: G-427BS
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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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Glucose Control Solutions

Glucose control solution

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagentSelf testing

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184600901
Basic UDI-DI: 6939184650001C3
Reference: 803GCS001990
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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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Blood Glucose Control Solution Level 1

Level 1

IVD Class CIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175030446
Basic UDI-DI: 6934175001C0102NW
Reference: 1A003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Safety summary (SSCP/SSP): NPI052-SR-101 · Rev. A.2
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

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Sinocare

H101, H102

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010721
Basic UDI-DI: 6934175001B0520P9
Reference: 7C005
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

Level 1, Level 2

IVD Class BIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009930
Basic UDI-DI: 6934175001C0501PG
Reference: REF 8C001, REF 8C002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

BSBE

ETGS4K

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Strong Biotechnologies, Inc.
Manufacturer SRN: CN-MF-000004362
UDI-DI: 06936736052454
Basic UDI-DI: 69367360BSBE0002SU
Reference: ETGS4K
EMDN: W01010308
EMDN description: POTASSIUM
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:59

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaning Solution(Direct Method)

1×20mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595776867
Basic UDI-DI: 693659570132MS
Reference: BF0132P
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 31.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009947
Basic UDI-DI: 6934175001C0501PG
Reference: 8C002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010738
Basic UDI-DI: 6934175001B0520P9
Reference: 7C006
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010745
Basic UDI-DI: 6934175001B0520P9
Reference: 7C007
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010752
Basic UDI-DI: 6934175001B0520P9
Reference: 7C008
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details