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EUDAMED Device Search

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

Last updated

31.07.2026 22:52

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663 device results listed.

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iFlash-Nuc IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720317
Basic UDI-DI: 692591270249HR
Reference: C86079G
EMDN: W0102100117
EMDN description: NUCLEOSOME ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CenpB IgG

iFlash-CenpB IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720300
Basic UDI-DI: 692591270257HQ
Reference: C86078G
EMDN: W0102100115
EMDN description: ANTI-CENTROMERE ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Rib-P0 IgG

iFlash-Rib-P0 IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720294
Basic UDI-DI: 692591270258HS
Reference: C86077G
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-ANA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718895
Basic UDI-DI: 692591270039HC
Reference: C89033G
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-dsDNA IgG

iFlash-dsDNA IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718796
Basic UDI-DI: 692591270038HA
Reference: C89015G
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiver Quantrix ANA25 IgG

BlueDiver Quantrix

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023682005
Basic UDI-DI: 542502368BDQANA3C
Reference: ANA25Q-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Granular12 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681824
Basic UDI-DI: 542502368BDDGRANULARDB
Reference: GR12DIV-24
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Synthetase10 IgG

BlueDiverDot Myositis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681732
Basic UDI-DI: 542502368BDDMYOSITISTF
Reference: SYN10DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Scleroderma10 IgG

BlueDiverDot Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681725
Basic UDI-DI: 542502368BDDSCLERODERMAKH
Reference: SCL10DIV-24
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Polymyositis/Scleroderma8 IgG

BlueDiverDot Polymyositis/Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681589
Basic UDI-DI: 542502368BDDPMSCLLT
Reference: PMS8DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Cytoplasm6 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681428
Basic UDI-DI: 542502368BDDCYTOPLASMKG
Reference: CY6DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Chromatin IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681398
Basic UDI-DI: 542502368BDDCHROMATIN6Y
Reference: CHRDIV-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot ANA8 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681305
Basic UDI-DI: 542502368BDDANAYE
Reference: ANA8DIV-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Granular12 IgG

BlueDot Granular

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680902
Basic UDI-DI: 542502368BDGRANULARQV
Reference: GR12D-24
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Scleroderma10 IgG

BlueDot Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680766
Basic UDI-DI: 542502368BDSCLERODERMAK9
Reference: SCL10D-24
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Myositis7 IgG

BlueDot Myositis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680742
Basic UDI-DI: 542502368BDMYOSITIS74
Reference: MYO7D-24
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Chromatin IgG

BlueDot Chromatin IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680568
Basic UDI-DI: 542502368BDCHROMATINFW
Reference: CHRD-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Polymyositis/Scleroderma8 IgG

BlueDot Polymyositis/Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680551
Basic UDI-DI: 542502368BDPMSCLCN
Reference: PMS8D-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Cytoplasm6 IgG

BlueDot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680407
Basic UDI-DI: 542502368BDCYTOPLASMUE
Reference: CY6D-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot ANA8 IgG

BlueDot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680308
Basic UDI-DI: 542502368BDANAZF
Reference: ANA8D-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details