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EUDAMED Device Search

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

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03.08.2026 14:01

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U02-010

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802096
Basic UDI-DI: B-06941571802096
Reference: U02-010
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-009

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802089
Basic UDI-DI: B-06941571802089
Reference: U02-009
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-008

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802072
Basic UDI-DI: B-06941571802072
Reference: U02-008
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-007

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802065
Basic UDI-DI: B-06941571802065
Reference: U02-007
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-006

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802058
Basic UDI-DI: B-06941571802058
Reference: U02-006
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802041
Basic UDI-DI: B-06941571802041
Reference: U02-005
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-004

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802034
Basic UDI-DI: B-06941571802034
Reference: U02-004
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802027
Basic UDI-DI: B-06941571802027
Reference: U02-003
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-002

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802010
Basic UDI-DI: B-06941571802010
Reference: U02-002
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

U02-001

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571802003
Basic UDI-DI: B-06941571802003
Reference: U02-001
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

B00-630

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571800634
Basic UDI-DI: B-06941571800634
Reference: B00-630
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

B00-610

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571800610
Basic UDI-DI: B-06941571800610
Reference: B00-610
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Blood glucose test strips

G-425-3S

IVD Annex II List BIVDDOn the marketSelf testingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184625034
Basic UDI-DI: B-06939184625034
Reference: G-425-3S
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

Blood glucose test strips

G-425-2S

IVD Annex II List BIVDDOn the marketSelf testingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184600260
Basic UDI-DI: B-06939184600260
Reference: G-425-2S
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

Blood glucose test strips

G-427BS

IVD Annex II List BIVDDOn the marketInstrumentSelf testingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184600178
Basic UDI-DI: B-06939184600178
Reference: G-427BS
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Malta
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Ino Blood Glucose Test Strips

VGS01

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211217
Basic UDI-DI: B-06937339211217
Reference: VGS01-010
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Portugal
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:34

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Bravo Blood Glucose Test Strips

VGS02

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211200
Basic UDI-DI: B-06937339211200
Reference: VGS02-991
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Portugal
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:34

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Bravo Blood Glucose Test Strips

VGS02

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211194
Basic UDI-DI: B-06937339211194
Reference: VGS02-998
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Portugal
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:34

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Rapid Test Cassette

HbA1c Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188708
Basic UDI-DI: B-06936983188708
Reference: OHA-402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Test voor urineweginfecties

Test voor urineweginfecties

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983167666
Basic UDI-DI: B-06936983167666
Reference: U031-04H
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details