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GlucoDr.S™ BLE Blood Glucose Test Strip

ABM-513S

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350629
Basic UDI-DI: 88061283ABM513SSGA
Reference: ABM-513S-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G11-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

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

GlucoDr.S™ Blood Glucose Test Strip

AGM-513S

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350421
Basic UDI-DI: 88061283AGM513SSJX
Reference: AGM-513S-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G06-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.One™ Blood Glucose Test Strip

AGM-4200

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128342020
Basic UDI-DI: 88061283AGM4200SF6
Reference: AGM-4200-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G03-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.auto™ A Blood Glucose Test Strip

AGM-4000

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128340125
Basic UDI-DI: 88061283AGM4000SEQ
Reference: AGM-4000-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G10-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.SuperSensor™ Blood Glucose Test Strip

AGM-2200

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128320042
Basic UDI-DI: 88061283AGM2200SEG
Reference: AGM-2200-S1-P4
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G02-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

GlucoDr.™ Blood Glucose Test Strip

AGM-2100

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

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128310524
Basic UDI-DI: 88061283AGM2100SE9
Reference: AGM-2100-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G01-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

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

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

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

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

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

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

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

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

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

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