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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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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

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214426
Basic UDI-DI: B-06933260214426
Reference: BT2501-HBA1C
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214396
Basic UDI-DI: B-06933260214396
Reference: BT2101-cTnl
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214389
Basic UDI-DI: B-06933260214389
Reference: CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck Myo Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214372
Basic UDI-DI: B-06933260214372
Reference: BT2102-Myo
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck BNP Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214365
Basic UDI-DI: B-06933260214365
Reference: BT2109-BNP
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

MyoCheck D-Dimer Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214358
Basic UDI-DI: B-06933260214358
Reference: BT2105-D-Dimer
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck PRL Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214341
Basic UDI-DI: B-06933260214341
Reference: BT2207-PRL
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck TES Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214334
Basic UDI-DI: B-06933260214334
Reference: BT2211-TES
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HCY Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214327
Basic UDI-DI: B-06933260214327
Reference: BT2221-HCY
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck E2 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214303
Basic UDI-DI: B-06933260214303
Reference: BT2212-E2
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214297
Basic UDI-DI: B-06933260214297
Reference: BT2501-HBA1C
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck FT3 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214280
Basic UDI-DI: B-06933260214280
Reference: BT2214-FT3
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck FT4 Quantitativer Schnelltest (Fluoreszenz Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214310
Basic UDI-DI: B-06933260214310
Reference: BT2215-FT4
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

06930317866553

48 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317866553
Basic UDI-DI: B-06930317866553
Reference: DNK-1901-63
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06930317861374

20 tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317861374
Basic UDI-DI: B-06930317861374
Reference: DNK-2117-1
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06930317830684

24 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317830684
Basic UDI-DI: B-06930317830684
Reference: DNK-1901-63
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802872

48 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802872
Basic UDI-DI: B-06930317802872
Reference: DNK-1901-54
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802810

24 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802810
Basic UDI-DI: B-06930317802810
Reference: DNK-1901-54
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802803

48 tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802803
Basic UDI-DI: B-06930317802803
Reference: DNK-1901-53
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details