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TREN

Last updated

22.09.2026 04:45

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Successful

Device

3533409

Actor

47688

Certificate

3340

Active filter:EMDN:W0105040516

64 device results listed.

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U-CardDx™ 200

Nipahvirus Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289853965
Basic UDI-DI
B-06933289853965
Reference
WRA6P0001
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.08.2026 22:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792734142
Basic UDI-DI
B-06955792734142
Reference
S3220E-48
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
-
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792734135
Basic UDI-DI
B-06955792734135
Reference
S3220E-24
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
-
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06928103011522

Single tube, 10 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Daan Gene Co., Ltd.
Manufacturer SRN
CN-MF-000025799
UDI-DI
06928103011522
Basic UDI-DI
B-06928103011522
Reference
DA1152
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Slovakia
Authorised representative
Lotus NL B.V.
Last updated
03.08.2026 12:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06928103011515

Large package, 10 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Daan Gene Co., Ltd.
Manufacturer SRN
CN-MF-000025799
UDI-DI
06928103011515
Basic UDI-DI
B-06928103011515
Reference
DA1151
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Slovakia
Authorised representative
Lotus NL B.V.
Last updated
03.08.2026 12:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06928103011508

Large package, 48 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Daan Gene Co., Ltd.
Manufacturer SRN
CN-MF-000025799
UDI-DI
06928103011508
Basic UDI-DI
B-06928103011508
Reference
DA1150
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Slovakia
Authorised representative
Lotus NL B.V.
Last updated
03.08.2026 12:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
01220000260139

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing
Manufacturer
ZeptoMetrix LLC
Manufacturer SRN
US-MF-000035245
UDI-DI
01220000260139
Basic UDI-DI
122000026NATERCK5
Reference
NATROTA-6MC-IVD
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Northern Ireland
Authorised representative
Emergo Europe B.V.
Last updated
17.07.2026 07:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
01220000260108

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing
Manufacturer
ZeptoMetrix LLC
Manufacturer SRN
US-MF-000035245
UDI-DI
01220000260108
Basic UDI-DI
122000026NATERCK5
Reference
NATNOV-6MC-IVD
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Northern Ireland
Authorised representative
Emergo Europe B.V.
Last updated
17.07.2026 07:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Xpert®

Xpert® Norovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Cepheid AB
Manufacturer SRN
SE-MF-000002020
UDI-DI
07332940000981
Basic UDI-DI
B-07332940000981
Reference
GXNOV-CE-10
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Netherlands
Authorised representative
-
Last updated
16.07.2026 19:55
Manufacturer productsView details
GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Uniogen Oy
Manufacturer SRN
FI-MF-000032341
UDI-DI
D-CDX-100-01-40UHC
Basic UDI-DI
B-CDX-100-01-40UHC
Reference
CDX-100-01-40
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Finland
Authorised representative
-
Last updated
13.07.2026 03:59
Manufacturer productsView details
GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Abacus Diagnostica Oy
Manufacturer SRN
FI-MF-000024114
UDI-DI
D-CDX-100-01-40JW
Basic UDI-DI
B-CDX-100-01-40JW
Reference
CDX-100-01-40
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Finland
Authorised representative
-
Last updated
13.07.2026 03:58
Manufacturer productsView details
GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Uniogen Oy
Manufacturer SRN
FI-MF-000032341
UDI-DI
D-CDX-100-01-20UH2
Basic UDI-DI
B-CDX-100-01-20UH2
Reference
CDX-100-01-20
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Finland
Authorised representative
-
Last updated
13.07.2026 03:58
Manufacturer productsView details
GenomEra Norovirus Assay kit

CDX-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Abacus Diagnostica Oy
Manufacturer SRN
FI-MF-000024114
UDI-DI
D-CDX-100-01-20JQ
Basic UDI-DI
B-CDX-100-01-20JQ
Reference
CDX-100-01-20
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Finland
Authorised representative
-
Last updated
13.07.2026 03:58
Manufacturer productsView details
Sentosa SA Norovirus RT-PCR Test v2.0 (4x24)

300202

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use
Manufacturer
Vela Operations Singapore Pte. Ltd.
Manufacturer SRN
SG-MF-000025684
UDI-DI
08885013953015
Basic UDI-DI
B-08885013953015
Reference
300202
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Germany
Authorised representative
Vela Diagnostics Germany GmbH
Last updated
10.07.2026 17:16
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit

PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056302002
Basic UDI-DI
B-08800056302002
Reference
R0210E
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RevoDx Norovirus genogroup I&II qPCR Kit

RevoDx Norovirus genogroup I&II qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387213103
Basic UDI-DI
B-08684387213103
Reference
IP202432-100
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Austria
Authorised representative
-
Last updated
09.07.2026 01:55
Manufacturer productsView details
RevoDx Norovirus genogroup I&II qPCR Kit

RevoDx Norovirus genogroup I&II qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08684387213097
Basic UDI-DI
B-08684387213097
Reference
IP202432-25
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
09.07.2026 01:55
Manufacturer productsView details
LyoSens Norovirus GI + GII Detection qPCR Kit

LYO30

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08683548258847
Basic UDI-DI
B-08683548258847
Reference
LYO30
EMDN
W0105040516
EMDN description
NOROVIRUS - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
09.07.2026 00:20
Manufacturer productsView details