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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 22:01

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Substrat/Substrate LINE

Substrat/Substrate LINE

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIWE2000203
Basic UDI-DI: ++ENTIWE20002V036A
Reference: WE200.02
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

IgA Konjugat/Conjugate (anti-human) LINE

IgG Konjugat/Conjugate (anti-human) LINE

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIWE4004209
Basic UDI-DI: ++ENTIWE400X2V02LT
Reference: WE400.42
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

Washing Buffer (20x concentrated)

Washing Buffer (20x concentrated)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIW00000S
Basic UDI-DI: ++ENTIW0000V018B
Reference: W0000
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

RF-SorboTech

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI16110106
Basic UDI-DI: ++ENTI16110XV02YC
Reference: 161101
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

TMB-Substrat/Substrate ELISA

TMB-Substrat/Substrate ELISA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI15110105
Basic UDI-DI: ++ENTI151101V03PH
Reference: 151101
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

PBS-Verdünnungspuffer/Dilution Buffer ELISA

PBS-Verdünnungspuffer/Dilution Buffer ELISA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI14130106
Basic UDI-DI: ++ENTI141X01V036F
Reference: 141301
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:09

Manufacturer products View details

PBS-Waschlösung/Washing Solution ELISA

PBS-Waschlösung/Washing Solution ELISA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI14120105
Basic UDI-DI: ++ENTI141201V02P9
Reference: 141201
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:08

Manufacturer products View details

Citrat Stopplösung/Stopping Solution ELISA

Citrat Stopplösung/Stopping Solution ELISA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI14110104
Basic UDI-DI: ++ENTI141101V03NW
Reference: 141101
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:08

Manufacturer products View details

IgG Konjugat/Conjugate (anti-human) ELISA

IgA Konjugat/Conjugate (anti-human) ELISA

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTI13110103
Basic UDI-DI: ++ENTI131X01V025S
Reference: 131101
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:08

Manufacturer products View details

Micro-Dx™ CE IVD

U-200-048

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-200-04848
Basic UDI-DI: B-U-200-04848
Reference: U-200-048
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

Micro-Dx™ CE IVD

U-200-024

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-200-0243S
Basic UDI-DI: B-U-200-0243S
Reference: U-200-024
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

Add-On 10 CE IVD

U-120-048

IVD generalIVDDNo longer on the marketKitProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-120-0484H
Basic UDI-DI: B-U-120-0484H
Reference: U-120-048
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

Add-On 10 CE IVD

U-120-024

IVD generalIVDDNo longer on the marketKitProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-120-02443
Basic UDI-DI: B-U-120-02443
Reference: U-120-024
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

UMD-SelectNA™ CE IVD

U-050-048

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-050-04857
Basic UDI-DI: B-U-050-04857
Reference: U-050-048
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

UMD-SelectNA™ CE IVD

U-050-024

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-050-0244R
Basic UDI-DI: B-U-050-0244R
Reference: U-050-024
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

SepsiTest™-UMD CE IVD

U-010-048

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-010-0483K
Basic UDI-DI: B-U-010-0483K
Reference: U-010-048
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

SepsiTest™-UMD CE IVD

U-010-024

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-010-02435
Basic UDI-DI: B-U-010-02435
Reference: U-010-024
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

PREP-MB DWP DNA/RNA Extraction Kit, Package P Set No. 2

-

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014363025
Basic UDI-DI: 466001436RA072XB
Reference: Р-120-P/9EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-MB DWP DNA/RNA Extraction Kit, Package P Set No. 3

-

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014363032
Basic UDI-DI: 466001436RA072XB
Reference: Р-121-P/9EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-MB MAX DNA Extraction Kit, Package A

-

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014363056
Basic UDI-DI: 466001436RA070X7
Reference: Р-103-A/8EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details