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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

01.08.2026 18:27

Sync status

Successful

Device

2989865

Actor

47523

Certificate

3174

Active filter:EMDN:W01050118

123 device results listed.

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06970895477062

Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN
CN-MF-000001539
UDI-DI
06970895477062
Basic UDI-DI
B-06970895477062
Reference
B281T025B0C0
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Greece
Authorised representative
SUNGO Europe B.V.
Last updated
30.06.2026 09:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970895477055

Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN
CN-MF-000001539
UDI-DI
06970895477055
Basic UDI-DI
B-06970895477055
Reference
B281T010B0C0
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Greece
Authorised representative
SUNGO Europe B.V.
Last updated
30.06.2026 09:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06970895475686

Clostridium Difficile TcdA Gene And TcdB Gene Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN
CN-MF-000001539
UDI-DI
06970895475686
Basic UDI-DI
B-06970895475686
Reference
B28201T2048
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Greece
Authorised representative
Medunion S.L.
Last updated
30.06.2026 09:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792731783

Toxigenic Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792731783
Basic UDI-DI
B-06955792731783
Reference
S3350E-48
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
France
Authorised representative
Obelis s.a.
Last updated
28.06.2026 20:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792731776

Toxigenic Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792731776
Basic UDI-DI
B-06955792731776
Reference
S3350E-24
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Romania
Authorised representative
Obelis s.a.
Last updated
28.06.2026 20:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06955792731769

Toxigenic Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Sansure Biotech Inc.
Manufacturer SRN
CN-MF-000011392
UDI-DI
06955792731769
Basic UDI-DI
B-06955792731769
Reference
S3350E-12-P
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
France
Authorised representative
Obelis s.a.
Last updated
28.06.2026 20:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
C. difficile Toxin B FIA

CDF B-F23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000002170
UDI-DI
06952804803810
Basic UDI-DI
B-06952804803810
Reference
CDF B-F23F3
EMDN
W0105011803
EMDN description
C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
28.06.2026 12:25
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
C. difficile Toxin A FIA

CDF A-F23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000002170
UDI-DI
06952804803797
Basic UDI-DI
B-06952804803797
Reference
CDF A-F23F3
EMDN
W0105011803
EMDN description
C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country
Netherlands
Authorised representative
Lotus NL B.V.
Last updated
28.06.2026 12:25
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Novodiag C. difficile

-

IVD generalNot specifiedNo longer on the marketSingle use
Manufacturer
Mobidiag Ltd.
Manufacturer SRN
FI-MF-000001215
UDI-DI
06430041761785
Basic UDI-DI
B-06430041761785
Reference
NVD-CD-012
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Finland
Authorised representative
-
Last updated
23.06.2026 10:33
Manufacturer productsView details
Amplidiag C. difficile+027 Kit

-

IVD generalNot specifiedNo longer on the marketSingle use
Manufacturer
Mobidiag Ltd.
Manufacturer SRN
FI-MF-000001215
UDI-DI
06430041761532
Basic UDI-DI
B-06430041761532
Reference
AD-CD-300
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Finland
Authorised representative
-
Last updated
23.06.2026 10:33
Manufacturer productsView details
EntericBio® Clostridioides difficile

-

IVD generalNot specifiedOn the market
Manufacturer
Serosep Limited
Manufacturer SRN
IE-MF-000020322
UDI-DI
05391513879166
Basic UDI-DI
B-05391513879166
Reference
EBCDA-V2
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Ireland
Authorised representative
-
Last updated
20.06.2026 05:34
Manufacturer productsView details
04049095030147

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030147
Basic UDI-DI
4049095C070100000JW
Reference
CRP0704
EMDN
W0105011801
EMDN description
C.DIFFICILE GDH DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095030154

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030154
Basic UDI-DI
4049095C080100000KH
Reference
CRP0804
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095030451

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030451
Basic UDI-DI
4049095C080100000KH
Reference
C0801C01-VK
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095030468

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030468
Basic UDI-DI
4049095C080100000KH
Reference
C0801K01-VK
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095030475

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030475
Basic UDI-DI
4049095C080100000KH
Reference
C0801K02-VK
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095030512

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030512
Basic UDI-DI
4049095C070100000JW
Reference
C0701C01-VK
EMDN
W0105011801
EMDN description
C.DIFFICILE GDH DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095030529

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030529
Basic UDI-DI
4049095C070100000JW
Reference
C0701K01-VK
EMDN
W0105011801
EMDN description
C.DIFFICILE GDH DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details
04049095030536

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095030536
Basic UDI-DI
4049095C070100000JW
Reference
C0701K02-VK
EMDN
W0105011801
EMDN description
C.DIFFICILE GDH DETECTION
First on market country
-
Authorised representative
-
Last updated
16.06.2026 22:40
Manufacturer productsView details