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193 device results listed.

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Myoglobin test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403091
Basic UDI-DI: 697029753051L3
Reference: HGCL03
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

MYO CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547499
Basic UDI-DI: 697015090000035H3
Reference: CMH0103
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin(CLIA)

105-005661-00、105-005678-00、105-005912-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065236
Basic UDI-DI: 69449040004L-MYO*******P4
Reference: 105-005661-00
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MYO) Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-012736-00、105-002238-00、105-002239-00、105-012735-00、105-004499-00、105-004500-00、105-002302-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032160
Basic UDI-DI: 69449040004JMYO********Z5
Reference: 105-002238-00
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603154

MYO（CLIA）

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603154
Basic UDI-DI: 69268026MD71D00001UX
Reference: MCL01901E
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Myoglobin

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711773
Basic UDI-DI: 692591270041GX
Reference: C89241-L
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

Access Myoglobin

973243

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231682
Basic UDI-DI: 150995901AccMyoUQ
Reference: 973243
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MyO) Diagnostic Kit

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762414
Basic UDI-DI: B-06971348762414
Reference: MF-33-25
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MyO) Diagnostic Kit

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760205
Basic UDI-DI: B-06971348760205
Reference: MF-33-20
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-R147142U

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R147142U
Basic UDI-DI: B-R147142U
Reference: R14714
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

D-R147132S

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R147132S
Basic UDI-DI: B-R147132S
Reference: R14713
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

D-R147122Q

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R147122Q
Basic UDI-DI: B-R147122Q
Reference: R14712
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

D-R147112N

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R147112N
Basic UDI-DI: B-R147112N
Reference: R14711
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Myoglobin (MYO)

IVDR_67_TTN_DUB-C_C_KIT_MYO

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599670
Basic UDI-DI: 0405686900807VR
Reference: 10995649
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Myoglobin

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414197180
Basic UDI-DI: 0405686900829W3
Reference: 10310277
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Quantia Myoglobin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: D-6L32-439E
Basic UDI-DI: B-6L32-439E
Reference: 6L32-43
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:28

Manufacturer products View details

D-6-86AW

Myoglobin (MYO) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-86AW
Basic UDI-DI: B-6-86AW
Reference: "REF: USIA00000077M, USIA00000078M"
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-50A9

Myoglobin (MYO) Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-50A9
Basic UDI-DI: B-6-50A9
Reference: "REF: USCA00000700, USCA00000701, USCA00000702, USCA00000703, USCA00000704, U86581045M"
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Myoglobin (Latex Immunoturbidimetric)

Myoglobin (Latex Immunoturbidimetric)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145555689
Basic UDI-DI: 69471455606WH
Reference: 130504010A
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST Myo

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301216
Basic UDI-DI: 4987595PF1021KWX
Reference: 30121
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7002 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details