Data / Medical devices / Dominican Republic / Metrix Dominicana S.R.L.
Metrix Dominicana S.R.L.: FDA-registered device maker in HAINA San Cristobal, Dominican Republic, 2 510(k) clearances
Metrix Dominicana S.R.L. is registered with the FDA (registration 3004102635) in HAINA San Cristobal, Dominican Republic. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004102635
- Address
- Parque Industrial Itabo, S.A. (piisa) Buliding 5, HAINA San Cristobal, Dominican Republic, --
- Owner or operator
- The Metrix Company (1937141)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 19, 1997
- Registered through
- 2026
- Brand names listed
- BAXTER HEALTHCARE CORPORATION ExactaMix, Baxter Healthcare Corporation A6001 - 5L EFFLUENT BAG, GAMBRO UF Solutions, Inc. A6001 - 5 L Effluent Bag, HCT, IMed Products, MSD CORMIX, SECURE, VYGON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, I.V. | KPE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Hemodialysis, Remote Accessories | MON | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2003 | K030888 | EVA EMPTY SOLUTION CONTAINER | KPE | Substantially Equivalent | Metrix Co. | accessdata.fda.gov |
| April 30, 1996 | K960581 | SECURE EVA DUAL CHAMBER MIXING BAG | KPE | Substantially Equivalent | Secure Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 2, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.