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

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Alinity

Alinity i Folate

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740130626
Basic UDI-DI: 038074AIP0814L8
Reference: 08P1542
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:30

Manufacturer products View details

Alinity

Alinity i Pepsinogen II

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740147563
Basic UDI-DI: 038074AIP0925LJ
Reference: 09P2501
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:30

Manufacturer products View details

Alinity

Alinity i STAT High Sensitive Troponin-I Reagent Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740130718
Basic UDI-DI: 038074AIP0813L6
Reference: 08P1301
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:30

Manufacturer products View details

ARCHITECT

ARCHITECT STAT High Sensitive Troponin-I

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740117948
Basic UDI-DI: 038074ARP0325P9
Reference: 03P2502
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:30

Manufacturer products View details

ARCHITECT

Architect 25-0H Vitamin D

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740116415
Basic UDI-DI: 038074ARP0502P7
Reference: 05P0201
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:29

Manufacturer products View details

ARCHITECT

ARCHITECT Pepsinogen II

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740019617
Basic UDI-DI: 038074ARD0965LF
Reference: 09D6501
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:29

Manufacturer products View details

ARCHITECT

ARCHITECT Folate

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740002084
Basic UDI-DI: 038074ARP0174PC
Reference: 01P7401
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:29

Manufacturer products View details

Cardiac Markers Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050287
Basic UDI-DI: 697492505000003T8
Reference: BYZKC0102
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

Inflammation Markers Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050140
Basic UDI-DI: 697492505000002T6
Reference: BYZKB0102
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

Hypertension Markers Control

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925054919
Basic UDI-DI: 697492505000025TJ
Reference: CFA0101
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050775
Basic UDI-DI: 697492505000005TC
Reference: BYZKH0102
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Control

Analyzer(automatic and non-automatic)

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925051468
Basic UDI-DI: 697492505000008TJ
Reference: CAB0101
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.09.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Preview™ Pregnancy Test

Strip, Cassette, Midstream (types M, M4, M18, MII and M9)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289813907
Basic UDI-DI: 69332898CE1214EU
Reference: W001P0775
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Denmark
Authorised representative: QbD RepS BV
Last updated: 22.09.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details

Bone Metabolism Markers Control

Analyzer(automatic and non-automatic)

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925054360
Basic UDI-DI: 697492505000023TE
Reference: CHA0101
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.09.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Speciality Control

Analyzer(automatic and non-automatic)

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925054094
Basic UDI-DI: 697492505000022TC
Reference: CEA0101
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.09.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

PD-L1 IHC 22C3 pharmDx

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesCompanion diagnosticsHuman tissuesKitProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700573001033
Basic UDI-DI: 570057R0301P3007C021903N6
Reference: SK00621-205
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: -
Safety summary (SSCP/SSP): D67624 · Rev. 5.00
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 22.09.2026 20:28

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

PD-L1 IHC 22C3 pharmDx

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesCompanion diagnosticsHuman tissuesKitProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700573004317
Basic UDI-DI: 570057R0301P3007C021903N6
Reference: SK00621-207
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: -
Safety summary (SSCP/SSP): D67624 · Rev. 5.00
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 22.09.2026 20:28

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

PD-L1 IHC 22C3 pharmDx

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesCompanion diagnosticsHuman tissuesKitProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700573006205
Basic UDI-DI: 570057R0301P3007C021903N6
Reference: SK00621-212
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: -
Safety summary (SSCP/SSP): D67624 · Rev. 5.00
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 22.09.2026 20:28

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

PD-L1 IHC 22C3 pharmDx

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesCompanion diagnosticsHuman tissuesKitProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700575019982
Basic UDI-DI: 570057R0301P3007C021903N6
Reference: SK00621-213
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: -
Safety summary (SSCP/SSP): D67624 · Rev. 5.00
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 22.09.2026 20:28

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

Ora-3D

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Vigilant Biosciences, Inc.
Manufacturer SRN: US-MF-000013534
UDI-DI: 00860000930949
Basic UDI-DI: B-00860000930949
Reference: 9000006
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Italy
Authorised representative: Vigilant Biosciences GmbH
Last updated: 22.09.2026 19:23

Manufacturer products Authorised representative products Authorised representative actors View details