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06971771202884

ECS-101（25PCS）

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771202884
Basic UDI-DI: B-06971771202884
Reference: ECS-101（25PCS）
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:03

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06971771201443

CRS-101（25pcs)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771201443
Basic UDI-DI: B-06971771201443
Reference: CRS-101
EMDN: W0101060112
EMDN description: CREATININE ANALYSIS TEST STRIPS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:03

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Veroval Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598216033
Basic UDI-DI: B-06942598216033
Reference: U031-04H-001
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 18:53

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04712558760546

eB-KCS

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingSelf testing

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558760546
Basic UDI-DI: B-04712558760546
Reference: 1220051
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:34

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ZuhauseTEST FOB Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433944
Basic UDI-DI: B-04260173433944
Reference: TFO-602H
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

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ZuhauseTEST Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433937
Basic UDI-DI: B-04260173433937
Reference: U031-04H-001
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

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ZuhauseTEST Vaginal pH Rapid TestPanel

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433630
Basic UDI-DI: B-04260173433630
Reference: IVPH-504H
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

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ZuhauseTEST Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433623
Basic UDI-DI: B-04260173433623
Reference: U031-04H
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433913
Basic UDI-DI: B-04260173433913
Reference: U031-04H
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

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ZuhauseTEST FOB Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04260173433722
Basic UDI-DI: B-04260173433722
Reference: TFO-602H
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 17:12

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Mivolis FOB Rapid Test Cassette

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 04066447834222
Basic UDI-DI: B-04066447834222
Reference: TFO-602H
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 15:41

Manufacturer products Authorised representative products Authorised representative actors View details

06978896414642

PT3,PT4L,PT4H,PT5,PT6E,PT6,PT8,PT9L,PT9G,PT10

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

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896414642
Basic UDI-DI: 697372013BGBG001B4
Reference: W-PT3-2-120
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: Germany
Safety summary (SSCP/SSP): D-BG-SSP-001 · Rev. 1.1
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:14

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Bowel Health (FOB) Rapid Test

One+Step Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178341
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602H-01
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Ireland
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 10:56

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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

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

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

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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

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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

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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