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197 device results listed.

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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

Dimension Myoglobin Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_MYO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013843
Basic UDI-DI: 0405686901284VL
Reference: 10444907
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Myoglobin

IVDR_67_LLB_DUB-C_C_KIT_Myoglbn

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961736
Basic UDI-DI: 0405686901455VP
Reference: 10381031
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex Myoglobin

IVDR_27_MAR EB_B_KIT_N_La_Myo

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768012808
Basic UDI-DI: 0405686900961W4
Reference: 10446607
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

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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: 00630414599663
Basic UDI-DI: 0405686900807VR
Reference: 10995648
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Myoglobin

IVDR_67_TTN_DUB-C_C_REAG_MYO

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414197197
Basic UDI-DI: 0405686900829W3
Reference: 10329242
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-654H

Myoglobin Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-654H
Basic UDI-DI: B-TD-HNKX-CED-654H
Reference: /
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

MYO Myoglobin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MYO706-AED7
Basic UDI-DI: B-MYO706-AED7
Reference: MYO706-AE10Y, MYO706-AE10N, MYO706-AE20Y, MYO706-AE20N
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MB601TR
Basic UDI-DI: B-MB601TR
Reference: MB6011Y, MB6012Y, MB6013Y, MB6014Y, MB6015Y, MB6011N, MB6012N, MB6013N, MB6014N, MB6015N
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX Myo STAT CMIA