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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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30.08.2026 20:49

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596 device results listed.

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SmarLumi

B-type Natriuretic Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857529
Basic UDI-DI: B-06933289857529
Reference: W382P0004
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

High Sensitive Cardiac Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857512
Basic UDI-DI: B-06933289857512
Reference: W381P0007
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

High Sensitive Cardiac Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857505
Basic UDI-DI: B-06933289857505
Reference: W381P0006
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

High Sensitive Cardiac Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857499
Basic UDI-DI: B-06933289857499
Reference: W381P0005
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

High Sensitive Cardiac Troponin I (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857482
Basic UDI-DI: B-06933289857482
Reference: W381P0004
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

2019-nCoV/Flu/RSV Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849920
Basic UDI-DI: B-06933289849920
Reference: WR38P0006
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

2019-nCoV/Flu/RSV Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849913
Basic UDI-DI: B-06933289849913
Reference: WR38P0005
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

2019-nCoV/Flu/RSV Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849906
Basic UDI-DI: B-06933289849906
Reference: WR38P0004
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

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: 06933289850506
Basic UDI-DI: 69332898CE3186FW
Reference: WK46
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 23:07

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: 06933289850513
Basic UDI-DI: 69332898CE3186FW
Reference: WK47
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

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: 06933289850520
Basic UDI-DI: 69332898CE3186FW
Reference: WK48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

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: 06933289850537
Basic UDI-DI: 69332898CE3186FW
Reference: WK49
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Inhibin B (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852951
Basic UDI-DI: B-06933289852951
Reference: WA13P0005
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Inhibin B (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852944
Basic UDI-DI: B-06933289852944
Reference: WA13P0004
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Inhibin B (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852937
Basic UDI-DI: B-06933289852937
Reference: WA13P0003
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Inhibin B (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852920
Basic UDI-DI: B-06933289852920
Reference: WA13P0002
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Prolactin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852876
Basic UDI-DI: B-06933289852876
Reference: WA63P0004
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Prolactin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852869
Basic UDI-DI: B-06933289852869
Reference: WA63P0003
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Prolactin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852852
Basic UDI-DI: B-06933289852852
Reference: WA63P0002
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Prolactin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852845
Basic UDI-DI: B-06933289852845
Reference: WA63P0001
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details