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glucose control solution

Glucose control solution

IVD Class CIVDR 2017/746On the marketNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715563540
Basic UDI-DI: 69507155CBGCQR
Reference: level 1
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Safety summary (SSCP/SSP): 1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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

blood glucose test strip

CGH100，CGH25，CGH30

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715563083
Basic UDI-DI: 69507155CBGTSP4
Reference: CGH100
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): 1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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

UMES 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: 06939184632988
Basic UDI-DI: 6939184630021BK
Reference: G-427B/G-427BS
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: 16.07.2026 10:38

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

Elite Medical 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: 06939184603674
Basic UDI-DI: 6939184600001AC
Reference: G-425-2S
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Safety summary (SSCP/SSP): IVDR-BL-BGMS-21 · Rev. A4
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:38

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

Blood glucose test strip

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715567890
Basic UDI-DI: 69507155KBGTSRU
Reference: KF-B10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 03:58

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

Blood glucose test strip

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715567937
Basic UDI-DI: 69507155KBGTSRU
Reference: KF-B12
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 03:58

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

G322001236CLE

HCA-TE-300

IVD Class AIVDR 2017/746Not intended for EU marketCompanion diagnosticsReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: G322001236CLE
Basic UDI-DI: ++G322001236CLE
Reference: NA
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

G322001218BL8

HCA-TE-300

IVD Class AIVDR 2017/746Not intended for EU marketReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: G322001218BL8
Basic UDI-DI: ++G322001218BL8
Reference: NA
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

ENNOLIFE Comprehensive II Panel

HCA-TE-300