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EUDAMED Device Search

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

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596 device results listed.

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U-Card™ 200

Vector-borne Pathogen Panel Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850070
Basic UDI-DI: B-06933289850070
Reference: WR41P0011
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859547
Basic UDI-DI: B-06933289859547
Reference: WA92P0002
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859530
Basic UDI-DI: B-06933289859530
Reference: WA92P0001
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Vector-borne Pathogen Panel Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849999
Basic UDI-DI: B-06933289849999
Reference: WR41P0010
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850544
Basic UDI-DI: 69332898CE3186FW
Reference: WK50
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850575
Basic UDI-DI: 69332898CE3186FW
Reference: WK53
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

WonDx-1001, WonDx-1002, WonDx-1003, WonDx-1004, WonDx-1005, WonDx-1006, WonDx-1007, WonDx-1008, U-CardDx 200-1001, U-CardDx 200-1002, U-CardDx 200-1003, U-CardDx 200-1004,U-CardDx 200-1005,U-CardDx 200-1006, U-CardDx 200-1007,U-CardDx 200-1008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850568
Basic UDI-DI: 69332898CE3186FW
Reference: WK52
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850551
Basic UDI-DI: 69332898CE3186FW
Reference: WK51
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Respiratory Pathogen Panel Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849937
Basic UDI-DI: B-06933289849937
Reference: WR39P0004
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Respiratory Pathogen Panel

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849944
Basic UDI-DI: B-06933289849944
Reference: WR39P0005
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Respiratory Pathogen Panel

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849951
Basic UDI-DI: B-06933289849951
Reference: WR39P0006
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

MTB Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853873
Basic UDI-DI: B-06933289853873
Reference: WE44P0001
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

MTB Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853880
Basic UDI-DI: B-06933289853880
Reference: WE44P0002
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

MTB Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853897
Basic UDI-DI: B-06933289853897
Reference: WE44P0003
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Lower Respiratory Pathogen Panel Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849975
Basic UDI-DI: B-06933289849975
Reference: WR40P0005
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Lower Respiratory Pathogen Panel Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849982
Basic UDI-DI: B-06933289849982
Reference: WR40P0006
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB INH&FQs Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850247
Basic UDI-DI: B-06933289850247
Reference: WR58P0004
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB INH&FQs Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850254
Basic UDI-DI: B-06933289850254
Reference: WR58P0005
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB INH&FQs Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850261
Basic UDI-DI: B-06933289850261
Reference: WR58P0006
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

6 Types of Diarrhea Pathogens Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289854047
Basic UDI-DI: B-06933289854047
Reference: WR90P0003
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details