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 16:13

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Device

3537230

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47759

Certificate

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Active filter:EMDN:W01050116

279 device results listed.

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AESKULISA® Clostridium tetani IgG

AESKULISA® Clostridium tetani IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use
Manufacturer
Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN
DE-MF-000026925
UDI-DI
04250289511582
Basic UDI-DI
B-04250289511582
Reference
6102
EMDN
W0105011609
EMDN description
TETANUS (CLOSTRIDIUM T.) - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
22.09.2026 11:23
LyoSens™

LYO142WS96

IVD Class CIVDDOn the marketKitProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08685115807274
Basic UDI-DI
868511580PCR142GK
Reference
LYO142WS96
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
22.09.2026 05:37
IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent
Manufacturer
Vitrosens Biotechnology Inc.
Manufacturer SRN
TR-MF-000026452
UDI-DI
08683548257468
Basic UDI-DI
868511580PCR102G7
Reference
CFP102P100
EMDN
W0105011606
EMDN description
YERSINIA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
22.09.2026 04:18
res2plex direct PCR

res2plex direct PCR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
FRIZ Biochem GmbH
Manufacturer SRN
DE-MF-000017533
UDI-DI
04260753890273
Basic UDI-DI
426075389fbc120TW
Reference
FBC120
EMDN
W0105011607
EMDN description
BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
11.08.2026 23:49
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289850209
Basic UDI-DI
B-06933289850209
Reference
WR47P0006
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.08.2026 22:46
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289850193
Basic UDI-DI
B-06933289850193
Reference
WR47P0005
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.08.2026 22:46
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289850186
Basic UDI-DI
B-06933289850186
Reference
WR47P0004
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.08.2026 22:46
VIASURE

VIASURE Mycoplasma genitalium with Macrolide Resistance Assay for BD MAX™ System (2x12 tubes, 24 test)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
CERTEST BIOTEC S.L.
Manufacturer SRN
ES-MF-000002193
UDI-DI
08435440258704
Basic UDI-DI
84354402MDXRESISTC_BMGMHP
Reference
444224
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
Spain
Authorised representative
-
Last updated
06.08.2026 23:01
D0020-Ureaplasma urealyticum-Positive PCR-Control

D0020-Ureaplasma urealyticum-Positive PCR-Control

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430973
Basic UDI-DI
B-04262420430973
Reference
D0020
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:45
K063-Brucella abortus-Ready to use PCR-Kit

K063-Brucella abortus-Ready to use PCR-Kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430584
Basic UDI-DI
B-04262420430584
Reference
K063
EMDN
W0105011601
EMDN description
BRUCELLA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
K017a-Leptospira pathogenic (Ready to use PCR-Kit)

K017a-Leptospira pathogenic (Ready to use PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430461
Basic UDI-DI
B-04262420430461
Reference
K017a
EMDN
W0105011604
EMDN description
LEPTOSPIRA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
FR001-Leptospira pathogenic (Realtime PCR-Kit)

FR001-Leptospira pathogenic (Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430287
Basic UDI-DI
B-04262420430287
Reference
FR001
EMDN
W0105011604
EMDN description
LEPTOSPIRA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
D0007-DNA Positive Control for Leptospira

D0007-DNA Positive Control for Leptospira

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430034
Basic UDI-DI
B-04262420430034
Reference
D0007
EMDN
W0105011604
EMDN description
LEPTOSPIRA - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
FR004-Bordetella pertussis (Realtime PCR-Kit)

FR004-Bordetella pertussis (Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Genekam Biotechnology AG
Manufacturer SRN
DE-MF-000035227
UDI-DI
04262420430027
Basic UDI-DI
B-04262420430027
Reference
FR004
EMDN
W0105011607
EMDN description
BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
05.08.2026 12:44
PerioPOC Pro

PerioPOC Pro

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
GENSPEED Biotech
Manufacturer SRN
AT-MF-000013008
UDI-DI
09120131770052
Basic UDI-DI
B-09120131770052
Reference
PPTK002
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
Austria
Authorised representative
-
Last updated
04.08.2026 16:50
RevoDx Haemophilus influenzae qPCR Kit

RevoDx Haemophilus influenzae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08683079717936
Basic UDI-DI
B-08683079717936
Reference
IP202252-100
EMDN
W0105011610
EMDN description
HAEMOPHILUS INFLUENZAE - NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
04.08.2026 09:25
RevoDx Neisseria Meningitidis qPCR Kit

RevoDx Neisseria Meningitidis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
08683079717776
Basic UDI-DI
B-08683079717776
Reference
IP202235-100
EMDN
W0105011611
EMDN description
NEISSERIA MENINGITIDIS - NA REAGENTS
First on market country
Türkiye
Authorised representative
-
Last updated
04.08.2026 09:24
06955792735675

Haemophilus influenzae (HI) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792735675
Basic UDI-DI
B-06955792735675
Reference
S3280E-48
EMDN
W0105011610
EMDN description
HAEMOPHILUS INFLUENZAE - NA REAGENTS
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:10
06955792735460

Vibrio Parahaemolyticus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792735460
Basic UDI-DI
B-06955792735460
Reference
S3208E-48
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:09
06955792735453

Vibrio Parahaemolyticus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792735453
Basic UDI-DI
B-06955792735453
Reference
S3208E-24
EMDN
W0105011699
EMDN description
BACTERIOLOGY - NA REAGENTS - OTHER
First on market country
France
Authorised representative
Obelis s.a.
Last updated
03.08.2026 22:09