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

03.08.2026 22:01

Sync status

Successful

Device

3006514

Actor

47531

Certificate

3181

Filters

Show filters

Active filter:EMDN:W01021090

337 device results listed.

Page 14 / 17

CSV XML

Sharay Anti-GBM IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761387
Basic UDI-DI: B-06975070761387
Reference: 18101001
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

BlueWell ASCA IgG ELISA

542502368ECROHN6V

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680025
Basic UDI-DI: B-05425023680025
Reference: ASCG02-96
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 06.07.2026 08:36

Manufacturer products View details

anti ox-LDL ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000667
Basic UDI-DI: B-04050598000667
Reference: K 7809
EMDN: W0102109023
EMDN description: LDL ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:39

Manufacturer products View details

anti-Sperm Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325012288
Basic UDI-DI: B-04049325012288
Reference: RE52001
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

Spermatozoa-Ab ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325001640
Basic UDI-DI: B-04049325001640
Reference: RE52029
EMDN: W0102109013
EMDN description: SPERM ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

ARAb Blocking RIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325001435
Basic UDI-DI: B-04049325001435
Reference: RE21031
EMDN: W0102109022
EMDN description: ACETYLCHOLIN RECEPTOR ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:07

Manufacturer products View details

HUMAN RHEUMA-LISA IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001353
Basic UDI-DI: B-03532672001353
Reference: HM 028HPE
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:42

Manufacturer products View details

HUMAN & ANIMAL RHEUMA-LISA IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000042615
UDI-DI: 03532672001346
Basic UDI-DI: B-03532672001346
Reference: HM 028PE
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:42

Manufacturer products View details

D-01169

50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Wellgrow Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000045201
UDI-DI: D-01169
Basic UDI-DI: B-01169
Reference: 340601HNE,340602HNE,340603HNE,340604HNE,340605HNE,340606HNE
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.07.2026 16:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-01067

50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Wellgrow Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000045201
UDI-DI: D-01067
Basic UDI-DI: B-01067
Reference: 50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.07.2026 16:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-0086L

50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Wellgrow Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000045201
UDI-DI: D-0086L
Basic UDI-DI: B-0086L
Reference: 50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-0066G

50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Wellgrow Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000045201
UDI-DI: D-0066G
Basic UDI-DI: B-0066G
Reference: 50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 04.07.2026 18:06

Manufacturer products Authorised representative products Authorised representative actors View details

Evo Autoimmune SPA

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 48058945154470
Basic UDI-DI: 8058945153AU3020AIHM
Reference: 3AU3020 AGA
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:18

Manufacturer products View details

EliA GBM Well

EliA GBM

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014630
Basic UDI-DI: 7333066BUDI0025LW
Reference: 14-5514-01
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

MuSK-Ab ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325029507
Basic UDI-DI: 4049325IVR06020002BR4
Reference: RE51021
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

Acetylcholine Receptor Autoantibodies (ARAb) RRA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325008229
Basic UDI-DI: 4049325IVR06020001BQZ
Reference: KIPIB21021
EMDN: W0102109022
EMDN description: ACETYLCHOLIN RECEPTOR ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

Acetylcholine Receptor Autoantibodies (ARAb) RRA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325033542
Basic UDI-DI: 4049325IVR06020001BQZ
Reference: 30221148
EMDN: W0102109022
EMDN description: ACETYLCHOLIN RECEPTOR ANTIBODIES
First on market country: -
Authorised representative: -
Last updated: 30.06.2026 12:40

Manufacturer products View details

Acetylcholine Receptor Autoantibodies (ARAb) RRA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325033559
Basic UDI-DI: 4049325IVR06020001BQZ
Reference: 30221149
EMDN: W0102109022
EMDN description: ACETYLCHOLIN RECEPTOR ANTIBODIES
First on market country: -
Authorised representative: -
Last updated: 30.06.2026 12:40

Manufacturer products View details

Anti-endometrial antibody IgM (EM-IgM) Dectection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522647936
Basic UDI-DI: B-06970522647936
Reference: DB1101
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-endometrial antibody IgG (EM-IgG) Dectection Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522647790
Basic UDI-DI: B-06970522647790
Reference: DB1001
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details