Public EUDAMED Search

EUDAMED Device Search

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

Last updated

02.08.2026 12:03

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Successful

Device

2993247

Actor

47524

Certificate

3174

Active filter:EMDN:W01021090

308 device results listed.

Page 13 / 16

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
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
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
Evo Autoimmune SPA

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
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
MuSK-Ab ELISA

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
Acetylcholine Receptor Autoantibodies (ARAb) RRA

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
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
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
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
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
Anti-ovarian antibody IgG (AOA-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
06970522640975
Basic UDI-DI
B-06970522640975
Reference
DB0601
EMDN
W0102109099
EMDN description
AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country
Spain
Authorised representative
Medunion S.L.
Last updated
30.06.2026 04:45
Anti-sperm antibody IgM (ASA-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
06970522640913
Basic UDI-DI
B-06970522640913
Reference
DB0501
EMDN
W0102109013
EMDN description
SPERM ANTIBODIES
First on market country
Spain
Authorised representative
Medunion S.L.
Last updated
30.06.2026 04:45
Anti-sperm antibody IgG (ASA-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
06970522640791
Basic UDI-DI
B-06970522640791
Reference
DB0401
EMDN
W0102109013
EMDN description
SPERM ANTIBODIES
First on market country
Spain
Authorised representative
Medunion S.L.
Last updated
30.06.2026 04:45
Anti-ovarian antibody IgM (AOA-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
06970522640692
Basic UDI-DI
B-06970522640692
Reference
DB0701
EMDN
W0102109099
EMDN description
AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country
Spain
Authorised representative
Medunion S.L.
Last updated
30.06.2026 04:45
06950617403678

IM4410460 IM4411460 IM4414460 IM4415460

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingInstrumentKit
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403678
Basic UDI-DI
69506174IM441460DZ
Reference
IM4415460
EMDN
W0102109014
EMDN description
ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
06950617403661

IM4410460 IM4411460 IM4414460 IM4415460

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingInstrumentKit
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403661
Basic UDI-DI
69506174IM441460DZ
Reference
IM4414460
EMDN
W0102109014
EMDN description
ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
06950617403654

IM4410460 IM4411460 IM4414460 IM4415460

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingInstrumentKit
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403654
Basic UDI-DI
69506174IM441460DZ
Reference
IM4411460
EMDN
W0102109014
EMDN description
ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
06950617403647

IM4410460 IM4411460 IM4414460 IM4415460

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingInstrumentKit
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403647
Basic UDI-DI
69506174IM441460DZ
Reference
IM4410460
EMDN
W0102109014
EMDN description
ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
Autobio Diagnostics Co., Ltd.
Manufacturer SRN
CN-MF-000003348
UDI-DI
06942359513340
Basic UDI-DI
697015090000315HC
Reference
CMQ1710
EMDN
W0102109014
EMDN description
ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country
Italy
Authorised representative
QbD RepS BV
Last updated
26.06.2026 19:51