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Last updated

21.09.2026 21:15

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Device

3253282

Actor

47660

Certificate

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Active filter:EMDN:W01050604

124 device results listed.

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LyoSens™

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998275392
Basic UDI-DI
868499827PCR96YG
Reference
LYO96WS48
EMDN
W0105060401
EMDN description
ASPERGILLUS - NA REAGENTS
First on market country
-
Authorised representative
-
Last updated
31.07.2026 22:55
Manufacturer productsView details
LyoSens™

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998275439
Basic UDI-DI
868499827PCR96YG
Reference
LYO96WS96
EMDN
W0105060401
EMDN description
ASPERGILLUS - NA REAGENTS
First on market country
-
Authorised representative
-
Last updated
31.07.2026 22:55
Manufacturer productsView details
ChainFor™

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998276191
Basic UDI-DI
868499827PCR96YG
Reference
CFP96P25
EMDN
W0105060401
EMDN description
ASPERGILLUS - NA REAGENTS
First on market country
-
Authorised representative
-
Last updated
31.07.2026 22:55
Manufacturer productsView details
ChainFor™

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998276207
Basic UDI-DI
868499827PCR96YG
Reference
CFP96P50
EMDN
W0105060401
EMDN description
ASPERGILLUS - NA REAGENTS
First on market country
-
Authorised representative
-
Last updated
31.07.2026 22:55
Manufacturer productsView details
ChainFor™

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998276214
Basic UDI-DI
868499827PCR96YG
Reference
CFP96P100
EMDN
W0105060401
EMDN description
ASPERGILLUS - NA REAGENTS
First on market country
-
Authorised representative
-
Last updated
31.07.2026 22:55
Manufacturer productsView details
04250592378544

eazyplex® Candida auris

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
AmplexDiagnostics GmbH
Manufacturer SRN
DE-MF-000014117
UDI-DI
04250592378544
Basic UDI-DI
42505923CAURJW
Reference
7854
EMDN
W0105060404
EMDN description
CANDIDA AURIS - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:42
Manufacturer productsView details
04250592376267

eazyplex® Pneumocystis jirovecii

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
AmplexDiagnostics GmbH
Manufacturer SRN
DE-MF-000014117
UDI-DI
04250592376267
Basic UDI-DI
425059237626A3
Reference
7626
EMDN
W0105060405
EMDN description
PNEUMOCYSTIS - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:42
Manufacturer productsView details
D-697994388Nc045ZVEN

Pneumocystis jirovecii Nucleic Acid Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN
CN-MF-000053775
UDI-DI
D-697994388Nc045ZVEN
Basic UDI-DI
B-697994388Nc045ZVEN
Reference
Nc045
EMDN
W0105060405
EMDN description
PNEUMOCYSTIS - NA REAGENTS
First on market country
Germany
Authorised representative
Crealkraft GmbH
Last updated
17.07.2026 04:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-697994388Nc044ZTED

Cryptococcus Nucleic Acid Detection Kit (CSF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN
CN-MF-000053775
UDI-DI
D-697994388Nc044ZTED
Basic UDI-DI
B-697994388Nc044ZTED
Reference
Nc044
EMDN
W0105060403
EMDN description
CRYPTOCOCCUS - NA REAGENTS
First on market country
Germany
Authorised representative
Crealkraft GmbH
Last updated
17.07.2026 04:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-697994388Nc043ZRE4

Aspergillus Nucleic Acid Detection Kit (Sputum/BALF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN
CN-MF-000053775
UDI-DI
D-697994388Nc043ZRE4
Basic UDI-DI
B-697994388Nc043ZRE4
Reference
Nc043
EMDN
W0105060401
EMDN description
ASPERGILLUS - NA REAGENTS
First on market country
Germany
Authorised representative
Crealkraft GmbH
Last updated
17.07.2026 04:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-697994388Fa045WP8X

Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN
CN-MF-000053775
UDI-DI
D-697994388Fa045WP8X
Basic UDI-DI
B-697994388Fa045WP8X
Reference
Fa045
EMDN
W0105060405
EMDN description
PNEUMOCYSTIS - NA REAGENTS
First on market country
Germany
Authorised representative
Crealkraft GmbH
Last updated
17.07.2026 04:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-697994388Fa044WM8L

Cryptococcus Nucleic Acid Detection Kit (Fluorescence, CSF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN
CN-MF-000053775
UDI-DI
D-697994388Fa044WM8L
Basic UDI-DI
B-697994388Fa044WM8L
Reference
Fa044
EMDN
W0105060403
EMDN description
CRYPTOCOCCUS - NA REAGENTS
First on market country
Germany
Authorised representative
Crealkraft GmbH
Last updated
17.07.2026 04:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-697994388Fa043WK8B

Aspergillus Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN
CN-MF-000053775
UDI-DI
D-697994388Fa043WK8B
Basic UDI-DI
B-697994388Fa043WK8B
Reference
Fa043
EMDN
W0105060401
EMDN description
ASPERGILLUS - NA REAGENTS
First on market country
Germany
Authorised representative
Crealkraft GmbH
Last updated
17.07.2026 04:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
VIASURE Candida auris Real Time PCR Detection Kit

VIASURE Candida auris Real Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
CERTEST BIOTEC S.L.
Manufacturer SRN
ES-MF-000002193
UDI-DI
08435440258261
Basic UDI-DI
84354402_MDXRESIST_CAUL3
Reference
VS-CAU101L
EMDN
W0105060404
EMDN description
CANDIDA AURIS - NA REAGENTS
First on market country
Spain
Authorised representative
-
Last updated
16.07.2026 12:19
Manufacturer productsView details
Candida auris ELITe MGB® Kit

Candida auris ELITe MGB® Kit

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
ElitechGroup S.p.A.
Manufacturer SRN
IT-MF-000005919
UDI-DI
08033891488598
Basic UDI-DI
803389148CAU739M
Reference
RTS203ING
EMDN
W0105060404
EMDN description
CANDIDA AURIS - NA REAGENTS
First on market country
Italy
Authorised representative
-
Last updated
16.07.2026 11:48
Manufacturer productsView details
LiveGene Analysis

LiveGene Analysis

IVD Class CIVDR 2017/746On the marketDirect markingMicrobial substancesProfessional testing
Manufacturer
Seqstant GmbH
Manufacturer SRN
DE-MF-000035679
UDI-DI
04170000059325
Basic UDI-DI
417000005932S-LGA-1006V
Reference
LGA-100
EMDN
W0105060499
EMDN description
MYCOLOGY NA REAGENTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
16.07.2026 08:45
Manufacturer productsView details
111917794233

SwiftX DNA

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
Manufacturer
Xpedite Diagnostics GmbH
Manufacturer SRN
DE-MF-000020021
UDI-DI
111917794233
Basic UDI-DI
PP12579SWIFTX.DNA29
Reference
SXD-25-IVD
EMDN
W0105060499
EMDN description
MYCOLOGY NA REAGENTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
15.07.2026 14:38
Manufacturer productsView details
C. Albicans-Q Real- Time PCR Kit

G2M708021

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent
Manufacturer
Genes 2Me Private Limited
Manufacturer SRN
IN-MF-000035953
UDI-DI
D-G2M708021FK
Basic UDI-DI
B-G2M708021FK
Reference
G2M708021, G2M708021R
EMDN
W0105060402
EMDN description
CANDIDA ALBICANS - NA REAGENTS
First on market country
Belgium
Authorised representative
Obelis s.a.
Last updated
13.07.2026 23:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
DermaGenius® 3.0 Complete Multiplex real-time PCR kit

PN-402

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
PathoNostics B.V.
Manufacturer SRN
NL-MF-000002705
UDI-DI
08719327498019
Basic UDI-DI
B-08719327498019
Reference
PN-402
EMDN
W0105060402
EMDN description
CANDIDA ALBICANS - NA REAGENTS
First on market country
Netherlands
Authorised representative
-
Last updated
09.07.2026 19:05
Manufacturer productsView details
LyoSens

LYO68WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08684998276924
Basic UDI-DI
B-08684998276924
Reference
LYO68
EMDN
W0105060404
EMDN description
CANDIDA AURIS - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
09.07.2026 06:21
Manufacturer productsView details