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EUDAMED update: Mar 13, 2025
US-MF-000001646US-MF-000001646SRN
An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.
View in glossary →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 →No certificates registered for this manufacturer.
Hologic is a medical device manufacturer registered in EUDAMED. The company has 87 devices on the EU market across 31 countries. Headquartered in San Diego, United States. Explore the regulatory profile, devices and certificates on MD Atlas.
Devices placed in 31 countries
2 approved members
1 EU importer places this manufacturer's devices
1 authorised representative routes this manufacturer's devices
No documents registered for this company yet.
Showing 1–25 of 87 devices.
| Product | Trade name | Reference / catalog number | UDI-DI code | Quantity | Status |
|---|---|---|---|---|---|
| Aptima Auto Detect Kit | Aptima Auto Detect Kit | 303013 | 15420045500273 | 1 | On the market |
| Aptima BV Assay | Aptima BV Assay | PRD-05186 | 15420045512023 | 1 | On the market |
| Aptima BV Assay | Aptima BV Assay | PRD-07662 | 15420045517066 | 1 | On the market |
| Aptima BV Assay | Aptima BV Assay | PRD-05186 | 15420045512030 | 1 | On the market |
| Aptima BV Assay | Aptima BV Assay | PRD-07662 | 15420045517059 | 1 | On the market |
| Aptima BV Assay Calibrator | Aptima BV Assay Calibrator | PRD-05188 | 15420045512047 | 5 | On the market |
| Aptima BV Assay Controls Kit | Aptima BV Assay Controls Kit | PRD-05187 | 15420045512054 | 5 | On the market |
| Aptima Cervical Specimen Collection and Transport Kit | Aptima Cervical Specimen Collection and Transport Kit | 302657 | 15420045509207 | 50 | On the market |
| Aptima Chlamydia trachomatis Assay | Aptima Chlamydia trachomatis Assay | 302925 | 15420045505407 | 1 | On the market |
| Aptima Chlamydia trachomatis Assay | Aptima Chlamydia trachomatis Assay | 302925 | 15420045505414 | 1 | On the market |
| Aptima CMV Quant Assay Calibrator | Aptima CMV Quant Assay Calibrator | PRD-05075 | 15420045514577 | 5 | On the market |
| Aptima Combo 2 Assay | Aptima Combo 2 Assay | PRD-05576 | 15420045512894 | 1 | On the market |
| Aptima Combo 2 Assay | Aptima Combo 2 Assay | PRD-05571 | 15420045512849 | 1 | On the market |
| Aptima Combo 2 Assay | Aptima Combo 2 Assay | PRD-05571 | 15420045512832 | 1 | On the market |
| Aptima Combo 2 Assay | Aptima Combo 2 Assay | PRD-05576 | 15420045512900 | 1 | On the market |
| Aptima Controls Kit | Aptima Controls Kit | 301110 | 15420045506237 | 5 | On the market |
| Aptima CV/TV Assay | Aptima CV/TV Assay | PRD-07665 | 15420045517080 | 1 | On the market |
| Aptima CV/TV Assay | Aptima CV/TV Assay | PRD-05189 | 15420045512078 | 1 | On the market |
| Aptima CV/TV Assay | Aptima CV/TV Assay | PRD-05189 | 15420045512061 | 1 | On the market |
| Aptima CV/TV Assay | Aptima CV/TV Assay | PRD-07665 | 15420045517073 | 1 | On the market |
| Aptima CV/TV Assay Calibrator | Aptima CV/TV Assay Calibrator | PRD-05191 | 15420045512085 | 5 | On the market |
| Aptima CV/TV Assay Controls Kit | Aptima CV/TV Assay Controls Kit | PRD-05190 | 15420045512092 | 5 | On the market |
| Aptima DBS Extraction Buffer | Aptima DBS Extraction Buffer | PRD-04772 | 15420045511811 | 1 | On the market |
| Aptima Herpes Simplex Viruses 1 & 2 Assay | Aptima Herpes Simplex Viruses 1 & 2 Assay | PRD-03568 | 15420045507227 | 1 | On the market |
| Aptima Herpes Simplex Viruses 1 & 2 Assay | Aptima Herpes Simplex Viruses 1 & 2 Assay | PRD-03568 | 15420045507210 | 1 | On the market |