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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

22.09.2026 11:56

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Successful

Device

3537178

Actor

47731

Certificate

3381

Active filter:EMDN:W0104080606

38 device results listed.

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U-CardDx™ 200

Carba Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289854054
Basic UDI-DI
B-06933289854054
Reference
WR88P0001
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.08.2026 22:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
U-Card™ 200

Carba Test

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289854061
Basic UDI-DI
B-06933289854061
Reference
WR88P0002
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
05.08.2026 18:19
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
U-Card™ 200

Carba Test

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289854078
Basic UDI-DI
B-06933289854078
Reference
WR88P0003
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
-
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
05.08.2026 14:19
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06930317892651

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN
CN-MF-000001133
UDI-DI
06930317892651
Basic UDI-DI
B-06930317892651
Reference
DNK-1901-20
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Türkiye
Authorised representative
Lotus NL B.V.
Last updated
03.08.2026 12:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06930317888319

24 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN
CN-MF-000001133
UDI-DI
06930317888319
Basic UDI-DI
B-06930317888319
Reference
DNK-1901-20
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Türkiye
Authorised representative
Lotus NL B.V.
Last updated
03.08.2026 12:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06930317829640

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN
CN-MF-000001133
UDI-DI
06930317829640
Basic UDI-DI
B-06930317829640
Reference
DNK-2607-2
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Türkiye
Authorised representative
JOYSUN GROUP S.L.U
Last updated
03.08.2026 12:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06930317812888

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN
CN-MF-000001133
UDI-DI
06930317812888
Basic UDI-DI
B-06930317812888
Reference
DNK-2607-1
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Türkiye
Authorised representative
JOYSUN GROUP S.L.U
Last updated
03.08.2026 12:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
04250592376090

eazyplex® SuperBug expert

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
AmplexDiagnostics GmbH
Manufacturer SRN
DE-MF-000014117
UDI-DI
04250592376090
Basic UDI-DI
42505923SBEXMF
Reference
7609
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:42
Manufacturer productsView details
04250592376076

eazyplex® SuperBug Acineto

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
AmplexDiagnostics GmbH
Manufacturer SRN
DE-MF-000014117
UDI-DI
04250592376076
Basic UDI-DI
42505923SBABKP
Reference
7607
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:42
Manufacturer productsView details
Xpert®

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940006525
Basic UDI-DI
B-07332940006525
Reference
GXCARBARP-CE-120
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
16.07.2026 19:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Xpert®

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940006518
Basic UDI-DI
B-07332940006518
Reference
GXCARBARP-CE-10
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
16.07.2026 19:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Xpert®

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940002015
Basic UDI-DI
B-07332940002015
Reference
GXCARBAR-CE-120
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
16.07.2026 19:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Xpert®

Xpert® Carba-R

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940001049
Basic UDI-DI
B-07332940001049
Reference
GXCARBAR-CE-10
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
16.07.2026 19:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit

RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN
TR-MF-000047330
UDI-DI
D-8683079717486E6
Basic UDI-DI
B-8683079717486E6
Reference
IP202207-100
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Italy
Authorised representative
-
Last updated
12.07.2026 16:23
Manufacturer productsView details
RIDA®Plex CRE EU 16 well Step 1

RIDA®Plex CRE EU 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044006463
Basic UDI-DI
B-09343044006463
Reference
21099S
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Germany
Authorised representative
R-Biopharm AG
Last updated
10.07.2026 23:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RIDA®Plex CRE EU 16 well Step 2

RIDA®Plex CRE EU 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044006456
Basic UDI-DI
B-09343044006456
Reference
21099P
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Germany
Authorised representative
R-Biopharm AG
Last updated
10.07.2026 23:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RIDA®Plex CRE 16 well Step 1

RIDA®Plex CRE 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044006449
Basic UDI-DI
B-09343044006449
Reference
21098S
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Germany
Authorised representative
R-Biopharm AG
Last updated
10.07.2026 23:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RIDA®Plex CRE 16 well Step 2

RIDA®Plex CRE 16 well

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044006432
Basic UDI-DI
B-09343044006432
Reference
21098P
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Germany
Authorised representative
R-Biopharm AG
Last updated
10.07.2026 23:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CRE Reference 24-well

Step 1 tubes for CRE Reference 24-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044004742
Basic UDI-DI
B-09343044004742
Reference
81099S
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Malta
Authorised representative
Advena Limited
Last updated
10.07.2026 23:43
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CRE Reference 24-well

Step 2 Plates for CRE Reference 24-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044004735
Basic UDI-DI
B-09343044004735
Reference
81099P
EMDN
W0104080606
EMDN description
NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country
Malta
Authorised representative
Advena Limited
Last updated
10.07.2026 23:43
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details