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EUDAMED Device Search

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

TREN

Last updated

22.09.2026 15:09

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Successful

Device

3537221

Actor

47734

Certificate

3381

Active filter:EMDN:W0105040307

28 device results listed.

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RapidFor™

VMD102

IVD Class CIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684595030448
Basic UDI-DI
868459503VMD102BD79
Reference
VMD102BD
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Germany
Authorised representative
-
Last updated
22.09.2026 02:32
Manufacturer productsView details
SmarLumi

Herpes simplex virus-1 lgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289859448
Basic UDI-DI
B-06933289859448
Reference
WA89P0004
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
10.08.2026 23:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SmarLumi

Herpes simplex virus-1 lgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289859417
Basic UDI-DI
B-06933289859417
Reference
WA89P0001
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
10.08.2026 23:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SmarLumi

Herpes simplex virus-1 lgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289859424
Basic UDI-DI
B-06933289859424
Reference
WA89P0002
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
10.08.2026 23:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SmarLumi

Herpes simplex virus-1 lgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289859431
Basic UDI-DI
B-06933289859431
Reference
WA89P0003
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
10.08.2026 23:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HSV-1 IgM CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
Autobio Diagnostics Co., Ltd.
Manufacturer SRN
CN-MF-000003348
UDI-DI
06942359552240
Basic UDI-DI
697015090000102GR
Reference
CMK0403
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Türkiye
Authorised representative
QbD RepS BV
Last updated
31.07.2026 20:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
iFlash-HSV-1 IgM

iFlash-HSV-1 IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912715597
Basic UDI-DI
692591270062H7
Reference
C88041M-L
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
+ENTIRE579110H

Herpes simplex Virus 1 (HSV 1) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIRE579110H
Basic UDI-DI
B-+ENTIRE579110H
Reference
RE57911
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:18
Manufacturer productsView details
+ENTIHSV1M05000E

NovaLisa® Herpes simplex Virus 1 (HSV 1) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIHSV1M05000E
Basic UDI-DI
B-+ENTIHSV1M05000E
Reference
HSV1M0500
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:14
Manufacturer productsView details
+ENTIHSV1M050DS0C

NovaLisa® Herpes simplex Virus 1 (HSV 1) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIHSV1M050DS0C
Basic UDI-DI
B-+ENTIHSV1M050DS0C
Reference
HSV1M050DS
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:14
Manufacturer productsView details
+ENTIEIA-419709

Herpes Simplex Virus 1 IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIEIA-419709
Basic UDI-DI
B-+ENTIEIA-419709
Reference
EIA-4197
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:13
Manufacturer productsView details
+ENTIDEHSV1M05000+

Herpes simplex Virus 1 (HSV 1) IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIDEHSV1M05000+
Basic UDI-DI
B-+ENTIDEHSV1M05000+
Reference
DEHSV1M0500
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:11
Manufacturer productsView details
D-IM4423123JC

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4423123JC
Basic UDI-DI
B-IM4423123JC
Reference
IM4423123
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Spain
Authorised representative
Humiss International B.V.
Last updated
14.07.2026 01:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-IM4422123J5

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4422123J5
Basic UDI-DI
B-IM4422123J5
Reference
IM4422123
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Spain
Authorised representative
Humiss International B.V.
Last updated
14.07.2026 01:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-IM4418123K4

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4418123K4
Basic UDI-DI
B-IM4418123K4
Reference
IM4418123
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Spain
Authorised representative
Humiss International B.V.
Last updated
14.07.2026 01:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-IM4419123KB

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
D-IM4419123KB
Basic UDI-DI
B-IM4419123KB
Reference
IM4419123
EMDN
W0105040307
EMDN description
HSV 1 IGM
First on market country
Spain
Authorised representative
Humiss International B.V.
Last updated
14.07.2026 01:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details