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EUDAMED update: Nov 25, 2025
US-MF-000043017Healgen Life Science LLC is a medical device manufacturer registered in EUDAMED. The company has 85 devices on the EU market across 2 countries. Headquartered in Houston, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →US-MF-000043017SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →No certificates registered for this manufacturer.
No documents registered for this company yet.
1 approved member
Showing 1–25 of 85 devices.
| Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|
| 25-OH-Vitamin D Test Kit (CLIA) | CIVD-301a | 20850076346410 | 1 | On the market |
| 25-OH-Vitamin D Test Kit (CLIA) | CIVD-301a | 10850076346413 | 1 | On the market |
| Alpha-fetoprotein Test Kit (CLIA) | CEAFP-301a | 20850076346311 | 1 | On the market |
| Alpha-fetoprotein Test Kit (CLIA) | CEAFP-301a | 10850076346314 | 1 | On the market |
| Anti-Müllerian Hormone Test Kit (CLIA) | CAAMH-301a | 20850076346205 | 1 | On the market |
| Anti-Müllerian Hormone Test Kit (CLIA) | CAAMH-301a | 10850076346208 | 1 | On the market |
| C-Peptide Test Kit (CLIA) | CIPEP(C)-201a | 10850076346352 | 1 | On the market |
| C-Peptide Test Kit (CLIA) | CIPEP(C)-201a | 20850076346359 | 1 | On the market |
| Carbohydrate Antigen 125 Test Kit (CLIA) | CECA125-301a | 10850076346345 | 1 | On the market |
| Carbohydrate Antigen 125 Test Kit (CLIA) | CECA125-301a | 20850076346342 | 1 | On the market |
| Carbohydrate Antigen 19-9 Test Kit (CLIA) | CECA199-301a | 10850076346338 | 1 | On the market |
| Carbohydrate Antigen 19-9 Test Kit (CLIA) | CECA199-301a | 20850076346335 | 1 | On the market |
| Cardiac Troponin I Test Kit (CLIA) | CDTRO-401a | 10850076346215 | 1 | On the market |
| Cardiac Troponin I Test Kit (CLIA) | CDTRO-401a | 20850076346212 | 1 | On the market |
| Cardiac Troponin T Test Kit (CLIA) | CDTNT-301a | 20850076346243 | 1 | On the market |
| Cardiac Troponin T Test Kit (CLIA) | CDTNT-301a | 10850076346246 | 1 | On the market |
| Estradiol Test Kit (CLIA) | CAE2-301a | 20850076346168 | 1 | On the market |
| Estradiol Test Kit (CLIA) | CAE2-301a | 10850076346161 | 1 | On the market |
| Ferritin Test Kit (CLIA) | CIFER-301a | 10850076346383 | 1 | On the market |
| Ferritin Test Kit (CLIA) | CIFER-301a | 20850076346380 | 1 | On the market |
| Folate Test Kit (CLIA) | CIFA-301a | 20850076346397 | 1 | On the market |
| Folate Test Kit (CLIA) | CIFA-301a | 10850076346390 | 1 | On the market |
| Follicle Stimulating Hormone Test Kit (CLIA) | CAFSH-301a | 20850076346175 | 1 | On the market |
| Follicle Stimulating Hormone Test Kit (CLIA) | CAFSH-301a | 10850076346178 | 1 | On the market |
| Free Thyroxine Test Kit (CLIA) | CKFT4-301a | 20850076346069 | 1 | On the market |
Showing 1–25 of 85 device families.
B-20850076346038B-20850076346045B-10850076346055B-20850076346052B-10850076346062B-20850076346069B-10850076346079B-20850076346076B-10850076346093B-20850076346090B-10850076346116B-20850076346113B-10850076346123B-20850076346120B-10850076346222B-20850076346229B-10850076346246B-20850076346243B-10850076346291B-20850076346298B-10850076346307B-20850076346304B-10850076346314B-20850076346311B-10850076346338Devices placed in 2 countries
1 authorised representative routes this manufacturer's devices