Public EUDAMED Search

EUDAMED Device Search

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

Last updated

22.09.2026 20:14

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Device

3539394

Actor

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Certificate

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Active filter:EMDN:W0105050103

41 device results listed.

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IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
Autobio Diagnostics Co., Ltd.
Manufacturer SRN
CN-MF-000003348
UDI-DI
06942359552042
Basic UDI-DI
697015090000099HV
Reference
CMK0103
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Türkiye
Authorised representative
QbD RepS BV
Last updated
31.07.2026 20:51
Toxoplasma gondii IgM (CLIA)

105-012530-00, 105-012531-00, 105-012533-00, 105-012534-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053020848
Basic UDI-DI
69449040004W-ToxoIgM***L5
Reference
105-012533-00
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:47
iFlash-Toxo IgM

iFlash-Toxo IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912715658
Basic UDI-DI
692591270102GS
Reference
C88030M-L
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:30
VIDAS® TOXO IgM

VIDAS® TOXO IgM

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent
Manufacturer
bioMérieux SA
Manufacturer SRN
FR-MF-000004436
UDI-DI
03573026064365
Basic UDI-DI
357302BUDI000073T5
Reference
30202
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
France
Authorised representative
-
Last updated
30.07.2026 20:47
LIAISON® Toxo IgM

LIAISON® Toxo IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent
Manufacturer
DiaSorin Italia S.p.A.
Manufacturer SRN
IT-MF-000029422
UDI-DI
08056771100786
Basic UDI-DI
805677131071044
Reference
310710
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Italy
Authorised representative
-
Last updated
28.07.2026 03:39
08054320950028

IDS TOXO IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Technogenetics S.p.A
Manufacturer SRN
IT-MF-000025331
UDI-DI
08054320950028
Basic UDI-DI
805432095ISID5002LQ
Reference
IS-ID5002
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Italy
Authorised representative
-
Last updated
17.07.2026 05:42
+ENTITOXM0460DS0Q

NovaLisa® Toxoplasma gondii IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTITOXM0460DS0Q
Basic UDI-DI
B-+ENTITOXM0460DS0Q
Reference
TOXM0460DS
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:20
+ENTITOXM04600S

NovaLisa® Toxoplasma gondii IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTITOXM04600S
Basic UDI-DI
B-+ENTITOXM04600S
Reference
TOXM0460
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:20
+ENTIRE5711109

Toxoplasma gondii IgM μ-capture

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIRE5711109
Basic UDI-DI
B-+ENTIRE5711109
Reference
RE57111
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:18
+ENTIEIA-386409

Toxoplasma gondii IgM μ-capture ELISA

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEIA-386409
Basic UDI-DI
B-+ENTIEIA-386409
Reference
EIA-3864
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:13
ADVIA Centaur Toxoplasma M

IVDR_67_TTN_DUB-C_C_KIT_Toxo M

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414208442
Basic UDI-DI
0405686901825W2
Reference
10310320
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:33
IMMULITE 2000 Toxoplasma IgM (µ-Capture)

IVDR_67_LLB_DUB-C_C_KIT_Toxoplasma IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN
GB-MF-000016339
UDI-DI
00630414972893
Basic UDI-DI
0405686901465VS
Reference
10381298
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
16.07.2026 00:27
D-R184163D

50 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R184163D
Basic UDI-DI
B-R184163D
Reference
R18416
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
15.07.2026 05:23
D-R184153B

30 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R184153B
Basic UDI-DI
B-R184153B
Reference
R18415
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
15.07.2026 05:23
D-R1841439

200 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R1841439
Basic UDI-DI
B-R1841439
Reference
R18414
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
15.07.2026 05:23
D-R1841337

100 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R1841337
Basic UDI-DI
B-R1841337
Reference
R18413
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
15.07.2026 05:23
D-R1841235

50 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R1841235
Basic UDI-DI
B-R1841235
Reference
R18412
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
15.07.2026 05:23
D-R1841133

30 Tests/Kit

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R1841133
Basic UDI-DI
B-R1841133
Reference
R18411
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
-
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
15.07.2026 05:23
IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-GCTOX(IgM)-302aBR
Basic UDI-DI
B-GCTOX(IgM)-302aBR
Reference
GCTOX(IgM)-302a
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:32
D-EIM4415117GL

TOXO IgM Antibody Chemiluminescent Immunoassay Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-EIM4415117GL
Basic UDI-DI
B-EIM4415117GL
Reference
EIM4415117
EMDN
W0105050103
EMDN description
TOXOPLASMA ANTIBODY IGM
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
13.07.2026 18:58