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Last updated

20.09.2026 12:44

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3108040

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Active filter:EMDN:W01050118

129 device results listed.

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06975447582256

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN
CN-MF-000001552
UDI-DI
06975447582256
Basic UDI-DI
B-06975447582256
Reference
106-0159-01
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Slovakia
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 22:50
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06974323011286

Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000012338
UDI-DI
06974323011286
Basic UDI-DI
B-06974323011286
Reference
A2340
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 18:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06974323011279

Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000012338
UDI-DI
06974323011279
Basic UDI-DI
B-06974323011279
Reference
A2340
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 18:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Clostridium difficile Antigen Rapid Tes

Clostridium difficile Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN
CN-MF-000001118
UDI-DI
06974238911121
Basic UDI-DI
B-06974238911121
Reference
HCDI058G
EMDN
W0105011801
EMDN description
C.DIFFICILE GDH DETECTION
First on market country
Italy
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Clostridium dificile GDH, Toxin A and Toxin B Combo Rapid Test

Clostridium dificile GDH, Toxin A and Toxin B Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN
CN-MF-000001118
UDI-DI
06974238910711
Basic UDI-DI
B-06974238910711
Reference
HCDT067G
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Italy
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Clostridium Difficile Real Time PCR Kit

Clostridium Difficile Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042225215
Basic UDI-DI
B-06971042225215
Reference
DD-0166-02
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 11:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PreventID® C. diff Combo Tox A + B

PreventID® C. diff Combo Tox A + B

IVD generalIVDDOn the marketKitReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598013469
Basic UDI-DI
B-04050598013469
Reference
KSTICDT625GP
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:50
Manufacturer productsView details
PreventID® C. diff Combo Tox A + B

PreventID® C. diff Combo Tox A + B

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598013452
Basic UDI-DI
B-04050598013452
Reference
KSTICDT625G10
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:50
Manufacturer productsView details
MutaPLEX C. difficile, PCR

MutaPLEX C. difficile, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598009448
Basic UDI-DI
B-04050598009448
Reference
KG194396
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:48
Manufacturer productsView details
STANDARD™ M10 C. difficile BT

M10-CBT-01

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
SD Biosensor Inc.
Manufacturer SRN
KR-MF-000009168
UDI-DI
08800111723117
Basic UDI-DI
88001117IPBA01MA05WV
Reference
11CDC20A
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
03.07.2026 20:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
00857031002059

C. DIFF QUIK CHEK COMPLETE

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing
Manufacturer
TECHLAB, Inc.
Manufacturer SRN
US-MF-000008412
UDI-DI
00857031002059
Basic UDI-DI
857031002CDIFFAGTOX001SJ
Reference
T30525C
EMDN
W0105011803
EMDN description
C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
03.07.2026 15:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CLOSTRIDIUM DIFFICILE GDH Ag VIRCLIA® MONOTEST

VCM108

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Vircell, S.L
Manufacturer SRN
ES-MF-000004099
UDI-DI
08436610290678
Basic UDI-DI
843661029VCM10801M3
Reference
VCM108
EMDN
W0105011801
EMDN description
C.DIFFICILE GDH DETECTION
First on market country
Spain
Authorised representative
-
Last updated
03.07.2026 14:58
Manufacturer productsView details
CLOSTRIDIUM DIFFICILE TOXINS REAL TIME PCR KIT

RTPCR020

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Vircell, S.L
Manufacturer SRN
ES-MF-000004099
UDI-DI
08436610290173
Basic UDI-DI
843661029RTPCR020017V
Reference
RTPCR020-LP
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Spain
Authorised representative
-
Last updated
03.07.2026 14:57
Manufacturer productsView details
CerTest CLIA Clostridium difficile Toxin A/B Ag

CerTest CLIA Clostridium difficile Toxin A/B Ag

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
CERTEST BIOTEC S.L.
Manufacturer SRN
ES-MF-000002193
UDI-DI
08435440259039
Basic UDI-DI
84354402CLIGASTROB_CDXYC
Reference
CL-CDX001
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Spain
Authorised representative
-
Last updated
03.07.2026 14:04
Manufacturer productsView details
CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS

CCAB-C

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
DIESSE Diagnostica Senese S.p.A
Manufacturer SRN
IT-MF-000013311
UDI-DI
08033891322779
Basic UDI-DI
803389132CCAB-C0099
Reference
82308
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Italy
Authorised representative
-
Last updated
03.07.2026 08:15
Manufacturer productsView details
CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH

CCGDH-C

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
DIESSE Diagnostica Senese S.p.A
Manufacturer SRN
IT-MF-000013311
UDI-DI
08033891322748
Basic UDI-DI
803389132CCGDH-C00QA
Reference
82306
EMDN
W0105011801
EMDN description
C.DIFFICILE GDH DETECTION
First on market country
Italy
Authorised representative
-
Last updated
03.07.2026 08:15
Manufacturer productsView details
Nucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR)

HWTS-EV032A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN
CN-MF-000012807
UDI-DI
06974849366198
Basic UDI-DI
697484936HWTS-EV032AYS
Reference
HWTS-EV032A
EMDN
W0105011802
EMDN description
C.DIFFICILE TOXIN A/B DETECTION
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 17:36
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
04049095210068

RIDA®UNITY C. difficile

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
R-Biopharm AG
Manufacturer SRN
DE-MF-000007993
UDI-DI
04049095210068
Basic UDI-DI
4049095UN08350000SS
Reference
UN0835
EMDN
W0105011804
EMDN description
C.DIFFICILE BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
01.07.2026 18:52
Manufacturer productsView details