Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

24.09.2026 22:31

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Device

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Certificate

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Active filter:Certificate number:V13 114578 0005

28 device results listed.

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blood glucose monitoring system

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715571828
Basic UDI-DI
69507155KKIT5SB
Reference
KF-B12
EMDN
V010402
EMDN description
LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country
Spain
Safety summary (SSCP/SSP)
1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
blood glucose monitoring system

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715571804
Basic UDI-DI
69507155KKIT3S7
Reference
KF-B12
EMDN
V010402
EMDN description
LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country
Spain
Safety summary (SSCP/SSP)
1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
blood glucose monitoring system

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715571798
Basic UDI-DI
69507155CKIT5PK
Reference
CGH10
EMDN
V010402
EMDN description
LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country
Spain
Safety summary (SSCP/SSP)
1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
blood glucose monitoring system

Blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715571781
Basic UDI-DI
69507155CKIT3PF
Reference
CGH10
EMDN
V010402
EMDN description
LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country
Spain
Safety summary (SSCP/SSP)
1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
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
06950715571774
Basic UDI-DI
69507155KBGCSH
Reference
level 1
EMDN
W010106010801
EMDN description
BLOOD TEST STRIPS CONTROLS
First on market country
Spain
Safety summary (SSCP/SSP)
1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
Blood glucose meter

KF-B12, GKF-B01, KF-B06, KF-B07, KF-B09, KF-B10

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715571583
Basic UDI-DI
69507155KBGMT5
Reference
KF-B12
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
First on market country
Spain
Safety summary (SSCP/SSP)
1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
Blood glucose test strip

KF-B12,GKF-B01,KF-B06,KF-B07,KF-B09,KF-B10

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
06950715567852
Basic UDI-DI
69507155KBGTSRU
Reference
KF-B06
EMDN
W0101060101
EMDN description
GLUCOSE TEST STRIPS
First on market country
Germany
Safety summary (SSCP/SSP)
1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
blood glucose monitoring system

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715567845
Basic UDI-DI
69507155KKIT4S9
Reference
KF-B06
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
First on market country
Germany
Safety summary (SSCP/SSP)
1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
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
blood glucose meter

CGH09,CGH10,CGH11,CGH25,CGH30

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715563175
Basic UDI-DI
69507155CBGMRD
Reference
CGH11
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
First on market country
Spain
Safety summary (SSCP/SSP)
1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
16.07.2026 10:48
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
blood glucose monitoring system

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715563076
Basic UDI-DI
69507155CKIT4PH
Reference
CGH11
EMDN
V010402
EMDN description
LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
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
IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715567869
Basic UDI-DI
69507155KKIT4S9
Reference
KF-B06
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
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
IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715567883
Basic UDI-DI
69507155KKIT4S9
Reference
KF-B10
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
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
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
IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715567906
Basic UDI-DI
69507155KKIT4S9
Reference
KF-B10
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
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
IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715567920
Basic UDI-DI
69507155KKIT4S9
Reference
KF-B12
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
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
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
IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715571811
Basic UDI-DI
69507155KKIT4S9
Reference
KF-B12
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
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
IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing
Manufacturer
Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000001077
UDI-DI
06950715563168
Basic UDI-DI
69507155CKIT4PH
Reference
CGH11
EMDN
V010402
EMDN description
LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country
-
Safety summary (SSCP/SSP)
1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative
SUNGO Europe B.V.
Last updated
07.07.2026 11:08