Public EUDAMED Search

EUDAMED Device Search

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

Last updated

25.08.2026 10:02

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Successful

Device

3108040

Actor

47631

Certificate

3281

Active filter:Manufacturer SRN:US-MF-000043017

106 device results listed.

Page 5 / 6

D-Dimer Test Kit (CLIA)

D-Dimer Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346284
Basic UDI-DI
B-10850076346284
Reference
CDDDI-301a
EMDN
W0103020503
EMDN description
D-DIMER
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Brain Natriuretic Peptide Test Kit (CLIA)

Brain Natriuretic Peptide Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346277
Basic UDI-DI
B-10850076346277
Reference
CDBNA-301a
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 04:37
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
10850076346260
Basic UDI-DI
B-10850076346260
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 04:37
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
10850076346253
Basic UDI-DI
B-10850076346253
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 04:37
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
10850076346246
Basic UDI-DI
B-10850076346246
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 04:37
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
10850076346239
Basic UDI-DI
B-10850076346239
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 04:37
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
10850076346222
Basic UDI-DI
B-10850076346222
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 04:37
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
10850076346215
Basic UDI-DI
B-10850076346215
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 04:37
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
10850076346208
Basic UDI-DI
B-10850076346208
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 04:37
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
10850076346192
Basic UDI-DI
B-10850076346192
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 04:37
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
10850076346185
Basic UDI-DI
B-10850076346185
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 04:37
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
10850076346178
Basic UDI-DI
B-10850076346178
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 04:37
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
10850076346161
Basic UDI-DI
B-10850076346161
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 04:37
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
10850076346154
Basic UDI-DI
B-10850076346154
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 04:37
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
10850076346147
Basic UDI-DI
B-10850076346147
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 04:37
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
10850076346130
Basic UDI-DI
B-10850076346130
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 04:36
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
10850076346123
Basic UDI-DI
B-10850076346123
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 04:36
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
10850076346116
Basic UDI-DI
B-10850076346116
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 04:36
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
10850076346109
Basic UDI-DI
B-10850076346109
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 04:36
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
10850076346093
Basic UDI-DI
B-10850076346093
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 04:36