Public EUDAMED Search

EUDAMED Device Search

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

Last updated

17.07.2026 01:19

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Successful

Device

2834528

Actor

47411

Certificate

3100

Active filter:Manufacturer SRN:US-MF-000043017

105 device results listed.

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N-terminal pro–B-type Natriuretic Peptide Test Kit (CLIA)

N-terminal pro–B-type Natriuretic Peptide Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346267
Basic UDI-DI
B-20850076346267
Reference
CDBNP-401a
EMDN
W01021301
EMDN description
BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:03
High-sensitivity Cardiac Troponin I Test Kit (CLIA)

High-sensitivity Cardiac Troponin I Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346250
Basic UDI-DI
B-20850076346250
Reference
CDHST-301a
EMDN
W01021306
EMDN description
TROPONIN I/T
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:03
Cardiac Troponin T Test Kit (CLIA)

Cardiac Troponin T Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346243
Basic UDI-DI
B-20850076346243
Reference
CDTNT-301a
EMDN
W01021306
EMDN description
TROPONIN I/T
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:03
Creatine Kinase-MB Isoenzyme Test Kit (CLIA)

Creatine Kinase-MB Isoenzyme Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346236
Basic UDI-DI
B-20850076346236
Reference
CDCRP-401a
EMDN
W01021311
EMDN description
CREATINE KINASE - MB MASS (IC)
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:03
Myoglobin Test Kit (CLIA)

Myoglobin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346229
Basic UDI-DI
B-20850076346229
Reference
CDMYO-401a
EMDN
W01021304
EMDN description
MYOGLOBIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Cardiac Troponin I Test Kit (CLIA)

Cardiac Troponin I Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346212
Basic UDI-DI
B-20850076346212
Reference
CDTRO-401a
EMDN
W01021306
EMDN description
TROPONIN I/T
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Anti-Müllerian Hormone Test Kit (CLIA)

Anti-Müllerian Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346205
Basic UDI-DI
B-20850076346205
Reference
CAAMH-301a
EMDN
W0102050215
EMDN description
ANTI-MÛLLERIAN HORMONE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Total Beta-Human Chorionic Gonadotropin Test Kit (CLIA)

Total Beta-Human Chorionic Gonadotropin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346199
Basic UDI-DI
B-20850076346199
Reference
CAHCG-301a
EMDN
W0102050206
EMDN description
B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Progesterone Test Kit (CLIA)

Progesterone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346182
Basic UDI-DI
B-20850076346182
Reference
CAPRO-301a
EMDN
W0102050106
EMDN description
PROGESTERONE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Prolactin Test Kit (CLIA)

Prolactin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346151
Basic UDI-DI
B-20850076346151
Reference
CAIPRL-301a
EMDN
W0102050108
EMDN description
PROLACTIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Testosterone Test Kit (CLIA)

Testosterone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346144
Basic UDI-DI
B-20850076346144
Reference
CATES-301a
EMDN
W0102050110
EMDN description
TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Follicle Stimulating Hormone Test Kit (CLIA)

Follicle Stimulating Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346175
Basic UDI-DI
B-20850076346175
Reference
CAFSH-301a
EMDN
W0102050104
EMDN description
FOLLICLE STIMULATING HORMONE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Estradiol Test Kit (CLIA)

Estradiol Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346168
Basic UDI-DI
B-20850076346168
Reference
CAE2-301a
EMDN
W0102050103
EMDN description
ESTRADIOL
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Luteinizing Hormone Test Kit (CLIA)

Luteinizing Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346137
Basic UDI-DI
B-20850076346137
Reference
CALH-301a
EMDN
W0102050105
EMDN description
LUTEINISING HORMONE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Serum Amyloid A Test Kit (CLIA)

Serum Amyloid A Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346120
Basic UDI-DI
B-20850076346120
Reference
CDSAA-401a
EMDN
W0102019099
EMDN description
SPECIFIC PROTEINS - OTHER
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Heparin-Binding Protein Test Kit (CLIA)

Heparin-Binding Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346113
Basic UDI-DI
B-20850076346113
Reference
CDHBP-301a
EMDN
W0102019099
EMDN description
SPECIFIC PROTEINS - OTHER
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Procalcitonin Test Kit (CLIA)

Procalcitonin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346106
Basic UDI-DI
B-20850076346106
Reference
CDPCT-401a
EMDN
W0102069013
EMDN description
PROCALCITONIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Interleukin 6 Test Kit (CLIA)

Interleukin 6 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346090
Basic UDI-DI
B-20850076346090
Reference
CDIL6-301a
EMDN
W01030609
EMDN description
INTERLEUKIN 6 (IL-6)
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
C-Reactive Protein Test Kit (CLIA)

C-Reactive Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346083
Basic UDI-DI
B-20850076346083
Reference
CDCRP-401a
EMDN
W01021308
EMDN description
HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Thyroid-Stimulating Hormone Test Kit (CLIA)

Thyroid-Stimulating Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346076
Basic UDI-DI
B-20850076346076
Reference
CKTSH-301a
EMDN
W01020410
EMDN description
THYROID STIMULATING HORMONE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02