Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

22.09.2026 08:45

Sync status

Successful

Device

3535546

Actor

47709

Certificate

3367

Filters

Show filters

Active filter:EMDN:W01021090

352 device results listed.

Page 3 / 18

CSV XML

BlueDot ASCA IgG + IgA

BlueDot

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680377
Basic UDI-DI: B-05425023680377
Reference: ASCCD-24
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell Intrinsic Factor IgG

542502368EGASTRITIS3C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680117
Basic UDI-DI: B-05425023680117
Reference: IF01-96
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueWell ASCA IgA ELISA

542502368ECROHN6V

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680001
Basic UDI-DI: B-05425023680001
Reference: ASCA02-96
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

IDS GBM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694002
Basic UDI-DI: B-05060169694002
Reference: IS-AI1703
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-GBM IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545686
Basic UDI-DI: 697015090000315HC
Reference: CMQ1705
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-GBM IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545662
Basic UDI-DI: 697015090000315HC
Reference: CMQ1703
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-SS-A IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720393
Basic UDI-DI: 692591270066HF
Reference: C89011G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
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-PCNA IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720232
Basic UDI-DI: 692591270264HM
Reference: C86108
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
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-Sm IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717867
Basic UDI-DI: 692591270064HB
Reference: C89010G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Scl-70 IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717225
Basic UDI-DI: 692591270068HK
Reference: C89013G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Jo-1 IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717119
Basic UDI-DI: 692591270067HH
Reference: C89014G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-SS-B IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717102
Basic UDI-DI: 692591270063H9
Reference: C89012G
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-GBM IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717072
Basic UDI-DI: 692591270091HE
Reference: C89002G
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA

BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

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

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416409
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02197C
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Croatia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Theresa RUO Kit

Theresa RUO kit

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

Manufacturer: Navolab Diagnosztika Kft
Manufacturer SRN: HU-MF-000025337
UDI-DI: 05999862454005
Basic UDI-DI: 599986245415L
Reference: TK-0001
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

ASCA Screen IgA + IgG Dot

BlueDot ASCA

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687031
Basic UDI-DI: 542502368BDCROHN99
Reference: AD ASCASD
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

BlueDiverDot Gastritis IgG

BlueDiverDot Gastritis

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681473
Basic UDI-DI: 542502368BDDGASTRITISC2
Reference: IFPCADIV-24
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDot Gastritis IgG

BlueDot Gastritis

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680469
Basic UDI-DI: 542502368BDGASTRITISLY
Reference: IFPCAD-24
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

SpermMar Test IgG antiserum

SPMG_S

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

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967002542
Basic UDI-DI: 5411967SPMGS135
Reference: SPMG_A
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:59

Manufacturer products View details

SpermMar Test IgA Single kit

SPMA_S

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

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967002566
Basic UDI-DI: 5411967SPMAS127
Reference: SPMA_S
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:52

Manufacturer products View details