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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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Barza AmnioTest

Barza Amniotest

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-710088P5
Basic UDI-DI: B-710088P5
Reference: 710088
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-6327F

Urinary Control

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6327F
Basic UDI-DI: B-6327F
Reference: /
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-6317D

Rheumatism Multi Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6317D
Basic UDI-DI: B-6317D
Reference: /
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-6307B

Immunology Multi Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6307B
Basic UDI-DI: B-6307B
Reference: /
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-6297S

Enzyme Multical Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6297S
Basic UDI-DI: B-6297S
Reference: /
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-6287Q

Enzyme Multical Calibrator

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6287Q
Basic UDI-DI: B-6287Q
Reference: /
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-6177K

Cardiac Markers Plus Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6177K
Basic UDI-DI: B-6177K
Reference: /
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-6167H

Lipid Quality Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6167H
Basic UDI-DI: B-6167H
Reference: /
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-6157F

Creatine Kinase MB Isozyme Calibrator

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-6157F
Basic UDI-DI: B-6157F
Reference: /
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-61279

Control Serum Level 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-61279
Basic UDI-DI: B-61279
Reference: /
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-61177

Control Serum Level 1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-61177
Basic UDI-DI: B-61177
Reference: /
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-61075

System Calibrator Level 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-61075
Basic UDI-DI: B-61075
Reference: /
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 03:17

Manufacturer products Authorised representative products Authorised representative actors View details

Clear&Simple Digital Pregnancy Rapid Test

DC811

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testingSingle use

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: D-5060337728072UX
Basic UDI-DI: B-5060337728072UX
Reference: 0811S7X001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat H1N1

601070050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989408
Basic UDI-DI: B-08908007989408
Reference: 601070050
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521000402
Basic UDI-DI: B-06974521000402
Reference: QC402
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

uE3 CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908997
Basic UDI-DI: B-06970150908997
Reference: CMN0402
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

HA CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908959
Basic UDI-DI: B-06970150908959
Reference: CMM0402
EMDN: W0102120103
EMDN description: HYALURONIC ACID
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

LN CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908942
Basic UDI-DI: B-06970150908942
Reference: CMM0302
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

Col IV CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908935
Basic UDI-DI: B-06970150908935
Reference: CMM0202
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

PIIINP CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908928
Basic UDI-DI: B-06970150908928
Reference: CMM0102
EMDN: W0102120104
EMDN description: PROCOLLAGEN III AMINO TERMINAL PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details