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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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01.08.2026 00:16

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74 device results listed.

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EXENT® Immunoglobulin Isotypes (GAM) Control Pack

MSR801.M

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020602
Basic UDI-DI: 5051700MSR801.MJ4
Reference: MSQ801.M
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Freelite Mx™ Lambda Free Kit

LK018.M.OPT

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

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700019897
Basic UDI-DI: 5051700LK018.M.OPTKT
Reference: LK018.M.OPT
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Freelite Mx™ Kappa Free Kit

LK016.M.OPT

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

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700019880
Basic UDI-DI: 5051700LK016.M.OPTJR
Reference: LK016.M.OPT
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Freelite® Lambda Free Control Pack

LK018.OPT

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

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700018753
Basic UDI-DI: 5051700LK018.OPT57
Reference: NQ018.OPT
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite Freelite Kappa Free Kit

LK016.OPT

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

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017213
Basic UDI-DI: 5051700LK016.OPT4H
Reference: LK016.OPT
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems

LK016.CB

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

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700012096
Basic UDI-DI: 5051700LK016.CBXD
Reference: LK016.CB
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems

LK018.CB

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

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700012102
Basic UDI-DI: 5051700LK018.CBXT
Reference: LK018.CB
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex FLC kappa

IVDR_27_MAR EB_C_PROF_REAG_N_La_FLC_2

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768031410
Basic UDI-DI: 0405686902230V4
Reference: 10482437
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

N Latex FLC lamdba

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768031427
Basic UDI-DI: 0405686902230V4
Reference: 10482438
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: -
Authorised representative: -
Last updated: 23.07.2026 03:18

Manufacturer products View details

Lambda Light Chain Antibody + Cal/Cont

Lambda Light Chain Antibody + Cal/Cont

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 80536177207262Q
Basic UDI-DI: B-80536177207262Q
Reference: TB1150
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 04:22

Manufacturer products View details

Kappa Light Chain Antibody + Cal/Cont

Kappa Light Chain Antibody + Cal/Cont

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 80536177207022A
Basic UDI-DI: B-80536177207022A
Reference: TB1140
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 04:22

Manufacturer products View details

Biossays Lambda Light Chain (Immunoturbidimetric)

Lambda Light Chain (Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145551322
Basic UDI-DI: 69471455569X4
Reference: 130508017S
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Kappa Light Chain (Immunoturbidimetric)

Kappa Light Chain (Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145551087
Basic UDI-DI: 69471455568X2
Reference: 130508016S
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex FLC lambda

IVDR_27_MAR EB_C_PROF_REAG_N_La_FLC_2

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414312439
Basic UDI-DI: 0405686902230V4
Reference: 10873768
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:33

Manufacturer products View details

N FLC Supplementary Reagent

IVDR_27_MAR EB_A_PROF_REAG_N_FLC_Sup

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414312446
Basic UDI-DI: 0405686900184V8
Reference: 10873769
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

Lambda Light Chain

I0223

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0223NC
Basic UDI-DI: B-I0223NC
Reference: I0223
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:02

Manufacturer products View details

Kappa Light Chain

I0222

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0222NA
Basic UDI-DI: B-I0222NA
Reference: I0222
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:02

Manufacturer products View details

IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent

IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-446470QA
Basic UDI-DI: B-446470QA
Reference: 446470
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent

IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-446440PZ
Basic UDI-DI: B-446440PZ
Reference: 446440
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method)

Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-152H50TSC4F
Basic UDI-DI: B-152H50TSC4F
Reference: 152H50TSC
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details