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MD Atlas update: Jun 26, 2026
US-MF-000018839Healgen Scientific Limited Liability Company is a medical device manufacturer registered in EUDAMED. The company has 270 devices on the EU market across 2 countries. Headquartered in Houston, TX, 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-000018839SRN
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 270 devices.
| Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|
| 25-OH-VD Control | FIVD-PN20 | D-FIVD-PN20HGCE | 1 | On the market |
| Adenovirus Antigen FIA Control Kit | FCADE-PN2 | D-FCADE-PN2HGV4 | 1 | On the market |
| Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) | FCADE-502a | D-FCADE-502aHGFE | 1 | On the market |
| Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) | FCADE-502Ca | D-FCADE-502CaHGHU | 1 | On the market |
| AFP Control | FEAFP-PN20 | D-FEAFP-PN20HG78 | 1 | On the market |
| AFP Quantitative Test Kit (Time-Resolved FIA) | FEAFP-302a | D-FEAFP-302aHGQH | 1 | On the market |
| AMH Control | FAAMH-PN20 | D-FAAMH-PN20HG3M | 1 | On the market |
| AMH Quantitative Test Kit (Time-Resolved FIA) | FAAMH-402a | D-FAAMH-402aHGMB | 1 | On the market |
| AMH Quantitative Test Kit (Time-Resolved FIA) | FAAMH-302a | D-FAAMH-302aHGLW | 1 | On the market |
| Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method) | 1AA15B01 | 00810173656900 | 1 | On the market |
| Beta-HCG Control | FAHCG-PN20 | D-FAHCG-PN20HG27 | 1 | On the market |
| Beta2-MG Control | FIMG-PN20 | D-FIMG-PN20HG7Q | 1 | On the market |
| BNP Control | FDBNA-PN20 | D-FDBNA-PN20HG3Z | 1 | On the market |
| BNP Quantitative Test Kit (Time-Resolved FIA) | FDBNA-402a | D-FDBNA-402aHGMP | 1 | On the market |
| Calcitonin Quantitative Test Kit (Time-Resolved FIA) | FECAL-402a | D-FECAL-402aHGLR | 1 | On the market |
| Calprotectin Quantitative Test Kit (Time-Resolved FIA) | FDCAL-602a | D-FDCAL-602aHGLL | 1 | On the market |
| Cardiac Markers Control | FDCAR-LP3 | D-FDCAR-LP3HG3V | 1 | On the market |
| CEA Control | FECEA-PN20 | D-FECEA-PN20HGXB | 1 | On the market |
| CEA Quantitative Test Kit (Time-Resolved FIA) | FECEA-402a | D-FECEA-402aHGH4 | 1 | On the market |
| CK-MB Control | FDCKM-PN20 | D-FDCKM-PN20HG9V | 1 | On the market |
| CK-MB Quantitative Test Kit (Time-Resolved FIA) | FDCKM-402a | D-FDCKM-402aHGTK | 1 | On the market |
| Cortisol Control | FKCOR-PN20 | D-FKCOR-PN20HGNH | 1 | On the market |
| Cortisol Quantitative Test Kit (Time-Resolved FIA) | FKCOR-402a | D-FKCOR-402aHG8A | 1 | On the market |
| Cortisol Quantitative Test Kit (Time-Resolved FIA) | FKCOR-302a | D-FKCOR-302aHG7V | 1 | On the market |
| COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab) | GCFCR-T525a-NN | D-GCFCR-T525a-NNHGR9 | 1 | On the market |
Showing 1–25 of 270 device families.
B-GCCOV-502a-H18BB-GCCOV-502a-H28DB-GCCOV-502a-H38FB-GCCOV-502a-H58KB-GCCOV-502a-H78PB-GCCOV-502a-H10GEB-GCCOV-502a-H15GQB-GCCOV-502a-H20GHB-GEPSA-402aHG87B-GEPSA-401aHG7YB-FCCOV-502aHG3BB-GEPSA-302aHG7SB-GEPSA-301aHG7KB-GAHCG-101a-1THGVMB-GAHCG-101a-2THGVUB-GAHCG-101a-5THGWHB-GAHCG-101b-1THGW2B-GAHCG-101b-2THGW9B-GAHCG-101b-5THGWWB-FCRSV-502aHGKSB-GAHCG-101d-1THGWUB-FDSAA-402aHGTRB-FDWCR-402aHGAZB-GAHCG-101d-2THGX3B-FDIL6-402aHGLNDevices placed in 2 countries
6 EU importers place this manufacturer's devices
2 authorised representatives route this manufacturer's devices