Public EUDAMED Search

EUDAMED Device Search

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

Last updated

21.09.2026 21:15

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Device

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Active filter:Manufacturer SRN:US-MF-000043017

106 device results listed.

Page 4 / 6

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
Free Thyroxine Test Kit (CLIA)

Free Thyroxine Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346069
Basic UDI-DI
B-20850076346069
Reference
CKFT4-301a
EMDN
W01020402
EMDN description
FREE THYROXINE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Total Thyroxine Test Kit (CLIA)

Total Thyroxine Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346052
Basic UDI-DI
B-20850076346052
Reference
CKTT4-301a
EMDN
W01020407
EMDN description
THYROXINE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Free Triiodothyronine Test Kit (CLIA)

Free Triiodothyronine Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346045
Basic UDI-DI
B-20850076346045
Reference
CKFT3-301a
EMDN
W01020401
EMDN description
FREE TRIIODOTHYRONINE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Total Triiodothyronine Test Kit (CLIA)

Total Triiodothyronine Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346038
Basic UDI-DI
B-20850076346038
Reference
CKTT3-301a
EMDN
W01020405
EMDN description
TRIIODOTHYRONINE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:02
Parathyroid Hormone Test Kit (CLIA)

Parathyroid Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346437
Basic UDI-DI
B-10850076346437
Reference
CIPTH-301a
EMDN
W0102060312
EMDN description
PARATHYROID HORMONE INTACT
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:40
N-MID Osteocalcin Test Kit (CLIA)

N-MID Osteocalcin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346420
Basic UDI-DI
B-10850076346420
Reference
CIMID(N)-301a
EMDN
W0102060311
EMDN description
OSTEOCALCINE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:40
25-OH-Vitamin D Test Kit (CLIA)

25-OH-Vitamin D Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346413
Basic UDI-DI
B-10850076346413
Reference
CIVD-301a
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:40
Vitamin B12 Test Kit (CLIA)

Vitamin B12 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346406
Basic UDI-DI
B-10850076346406
Reference
CIVB12-301a
EMDN
W0102070204
EMDN description
VITAMIN B12
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:40
Folate Test Kit (CLIA)

Folate Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346390
Basic UDI-DI
B-10850076346390
Reference
CIFA-301a
EMDN
W0102070103
EMDN description
FOLATE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Ferritin Test Kit (CLIA)

Ferritin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346383
Basic UDI-DI
B-10850076346383
Reference
CIFER-301a
EMDN
W0102070102
EMDN description
FERRITIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
S100 Protein Test Kit (CLIA)

S100 Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346376
Basic UDI-DI
B-10850076346376
Reference
CLS100-301a
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Insulin Test Kit (CLIA)

Insulin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346369
Basic UDI-DI
B-10850076346369
Reference
CIINS-301a
EMDN
W0102060103
EMDN description
INSULIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
C-Peptide Test Kit (CLIA)

C-Peptide Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346352
Basic UDI-DI
B-10850076346352
Reference
CIPEP(C)-201a
EMDN
W0102060101
EMDN description
C-PEPTIDE
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Carbohydrate Antigen 125 Test Kit (CLIA)

Carbohydrate Antigen 125 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346345
Basic UDI-DI
B-10850076346345
Reference
CECA125-301a
EMDN
W0102030106
EMDN description
CANCER ANTIGEN 125
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Carbohydrate Antigen 19-9 Test Kit (CLIA)

Carbohydrate Antigen 19-9 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346338
Basic UDI-DI
B-10850076346338
Reference
CECA199-301a
EMDN
W0102030103
EMDN description
CANCER ANTIGEN 19-9
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Carcinoembryonic Antigen Test Kit (CLIA)

Carcinoembryonic Antigen Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346321
Basic UDI-DI
B-10850076346321
Reference
CECEA-301a
EMDN
W0102030112
EMDN description
CARCINOEMBRYONIC ANTIGEN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Alpha-fetoprotein Test Kit (CLIA)

Alpha-fetoprotein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346314
Basic UDI-DI
B-10850076346314
Reference
CEAFP-301a
EMDN
W0102039001
EMDN description
ALPHAFETOPROTEIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Heart-type Fatty Acid Binding Protein Test Kit (CLIA)

Heart-type Fatty Acid Binding Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346307
Basic UDI-DI
B-10850076346307
Reference
CDFAB-401a
EMDN
W01021302
EMDN description
HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Lipoprotein-associated Phospholipase A2 Test Kit (CLIA)

Lipoprotein-associated Phospholipase A2 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346291
Basic UDI-DI
B-10850076346291
Reference
CDPLA2-401a
EMDN
W01021312
EMDN description
LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39