Manufacturer registered with FDA
Macrolab Asociados S.A.S.
ENVIGADO, Colombia. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21,623 registrations outside the US
- Establishments
- 1Colombia
Registered in 2 markets
Where regulators' registries name Macrolab Asociados S.A.S. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Macrolab Asociados S.A.S. | 2 device types | — | Below |
| Colombia | INVIMA | Registration holder | MACROLAB ASOCIADOS S.A.SMACROLAB ASOCIADOS LTDA. · MACROLAB ASOCIADOS S.A.S. | 1,623 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Macrolab Asociados S.A.S. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | EcodentEcodent Mint * 100 yard | 2003 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | — | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MACROLAB ASOCIADOS S.A.S.FDA reg. 3004083336 | MEDELLIN Antioquia, Colombia | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9057003). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.