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FOB Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104401
Basic UDI-DI: 6970277510000BXD
Reference: TFO-N601
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Sediment Calibrator

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053068581
Basic UDI-DI: 69449040AB760000364
Reference: 105-043513-00
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:57

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Carbon Dioxide (CO2) Kit (Enzymic Method)

105-002189-00、105-002190-00、105-002191-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037660
Basic UDI-DI: 69449040004ECO2********LD
Reference: 105-002189-00
EMDN: W0101060601
EMDN description: CARBON DIOXIDE - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

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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

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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

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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

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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

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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

Sinocare

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010769
Basic UDI-DI: 6934175001B0520P9
Reference: 7C009
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: 06934175010776
Basic UDI-DI: 6934175001B0520P9
Reference: 7C010
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 2017/746Not intended for EU marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026081
Basic UDI-DI: 6934175001B0520P9
Reference: REF 7C005, REF 7C006, REF 7C007, REF 7C008, REF 7C009, REF 7C010, REF 7D005, REF 7D006, REF 7D007, REF 7D008
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: 06934175026098
Basic UDI-DI: 6934175001B0520P9
Reference: 7D006
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: 06934175026104
Basic UDI-DI: 6934175001B0520P9
Reference: 7D007
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: 06934175026111
Basic UDI-DI: 6934175001B0520P9
Reference: 7D008
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