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EUDAMED Device Search

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

Last updated

01.08.2026 13:11

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Device

2989354

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Certificate

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Active filter:EMDN:W0105040614

14 device results listed.

Page 1 / 1

+ENTIHANM06700_

NovaLisa® Hantavirus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIHANM06700_
Basic UDI-DI
B-+ENTIHANM06700_
Reference
HANM0670
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:14
+ENTIHANG06700W

NovaLisa® Hantavirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTIHANG06700W
Basic UDI-DI
B-+ENTIHANG06700W
Reference
HANG0670
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:14
+ENTI301140430C

Hantavirus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTI301140430C
Basic UDI-DI
B-+ENTI301140430C
Reference
30114043
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:06
+ENTI301140420B

Hantavirus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN
DE-MF-000025020
UDI-DI
+ENTI301140420B
Basic UDI-DI
B-+ENTI301140420B
Reference
30114042
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 13:06
Hantavirus lgG/lgM Rapid Test Cassette

Hantavirus lgG/lgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN
CN-MF-000010710
UDI-DI
D-IHVGM-402G6
Basic UDI-DI
B-IHVGM-402G6
Reference
IHVGM-402
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
MedNet EC-REP GmbH
Last updated
14.07.2026 01:09
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-GCHV(IgM)-402aVU
Basic UDI-DI
B-GCHV(IgM)-402aVU
Reference
GCHV(IgM)-402a
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:28
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCHV(IgM)-402aHGY5
Basic UDI-DI
B-GCHV(IgM)-402aHGY5
Reference
GCHV(IgM)-402a
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:28
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-GCHV(IgG/IgM)-402aLS
Basic UDI-DI
B-GCHV(IgG/IgM)-402aLS
Reference
GCHV(IgG/IgM)-402a
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:28
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-GCHV(IgG/IgM)-402aHGXA
Basic UDI-DI
B-GCHV(IgG/IgM)-402aHGXA
Reference
GCHV(IgG/IgM)-402a
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
14.07.2026 00:28
Reageana DOBRAVA-HANTAAN IgG EIA

Reagena DOBRAVA-HANTAAN IgG EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing
Manufacturer
Reagena Oy
Manufacturer SRN
FI-MF-000002804
UDI-DI
D-114302LW
Basic UDI-DI
B-114302LW
Reference
114302
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Slovenia
Authorised representative
-
Last updated
11.07.2026 05:48
Reagena PUUMALA IgG EIA

Reagena PUUMALA IgG EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing
Manufacturer
Reagena Oy
Manufacturer SRN
FI-MF-000002804
UDI-DI
D-114301LU
Basic UDI-DI
B-114301LU
Reference
114301
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Finland
Authorised representative
-
Last updated
11.07.2026 05:48
Reagena DOBRAVA-HANTAAN IgM EIA

Reagena DOBRAVA-HANTAAN IgM EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKit
Manufacturer
Reagena Oy
Manufacturer SRN
FI-MF-000002804
UDI-DI
D-114202LR
Basic UDI-DI
B-114202LR
Reference
114202
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Slovenia
Authorised representative
-
Last updated
11.07.2026 05:48
Reagena PUUMALA IgM EIA

Reagena PUUMALA IgM EIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing
Manufacturer
Reagena Oy
Manufacturer SRN
FI-MF-000002804
UDI-DI
D-114201LP
Basic UDI-DI
B-114201LP
Reference
114201
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
Finland
Authorised representative
-
Last updated
11.07.2026 05:48
Hantavirus Renal Syndrome Type II  Real Time RT-PCR Kit

Hantavirus Renal Syndrome Type II  Real Time RT-PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042229381
Basic UDI-DI
B-06971042229381
Reference
QR-0236-02
EMDN
W0105040614
EMDN description
HANTAVIRUS / BUNYAVIRUS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:04