Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TR EN

Last updated

01.08.2026 01:12

Sync status

Successful

Device

2988209

Actor

47517

Certificate

3174

Filters

Show filters

Active filter:EMDN:W010408

1000+ device results listed.

Page 50 / 50

CSV XML

MutaPLEX® PRE/RU/LA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598003903
Basic UDI-DI: B-04050598003903
Reference: KG1913-96
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:43

Manufacturer products View details

MutaPLEX® MRSA, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002494
Basic UDI-DI: B-04050598002494
Reference: KG190396
EMDN: W0104080602
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:41

Manufacturer products View details

MutaPLEX® EU/BAC/BIF, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598001145
Basic UDI-DI: B-04050598001145
Reference: KG1912-96
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:40

Manufacturer products View details

MutaPLEX® EU/BAC/BIF, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000100
Basic UDI-DI: B-04050598000100
Reference: KG1912-384
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:38

Manufacturer products View details

MutaPLEX® AKM/FAEP, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000094
Basic UDI-DI: B-04050598000094
Reference: KG1911-384
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:38

Manufacturer products View details

MutaPLEX® AKM/FAEP, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598000001
Basic UDI-DI: B-04050598000001
Reference: KG1911-96
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:38

Manufacturer products View details

Carbapenem Resistance Gene Detection Kit(Fluorescence PCR)

Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807194077RD
Basic UDI-DI: B-000012807194077RD
Reference: HWTS-OT045
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

OXA23 Carbapenemase Detection Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807161082PG
Basic UDI-DI: B-000012807161082PG
Reference: HWTS-OT118
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Carbapenemase Detection Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807160083PB
Basic UDI-DI: B-000012807160083PB
Reference: HWTS-OT085
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ MDRO Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102886
Basic UDI-DI: 924010MR10289KS
Reference: MR10288Z
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Rifampicin & Isoniazid Resistant MTB Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304835
Basic UDI-DI: 89080153043B1280L8
Reference: 3B1280/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MRSA Real-Time PCR Detection kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930429
Basic UDI-DI: 89080153043B1283LE
Reference: 3B1283/C
EMDN: W0104080602
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® UTI AST Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930399
Basic UDI-DI: 89080153043B343NJ
Reference: 3B343/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® AST Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930368
Basic UDI-DI: 8906213933B361YT
Reference: 3B361/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Carbapenem Resistance Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930337
Basic UDI-DI: 8906213933B290YV
Reference: 3B289/C
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® UTI ID Panel Kit

IVD Class CIVDR 2017/746On the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930245
Basic UDI-DI: 8906213933B319YU
Reference: 3B319/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® VRE Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930306
Basic UDI-DI: 8906213933B373Z2
Reference: 3B373/C
EMDN: W0104080604
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Rifampicin Resistant MTB Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930276
Basic UDI-DI: 8906213933B1281SV
Reference: 3B1281/C
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 21:55

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

Enterecoccus spp./Van A/B Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276429
Basic UDI-DI: 868521452PCR150G3
Reference: CFP150P25
EMDN: W0104080590
EMDN description: TARGETED RESISTANCE TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:39

Manufacturer products View details

ChainFor™

ABR ID-23 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031940
Basic UDI-DI: 868521452PCR125G4
Reference: CFP125P25
EMDN: W0104080590
EMDN description: TARGETED RESISTANCE TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:37

Manufacturer products View details