Data / Medical devices / Dominican Republic / Convatec Dominican Republic, Inc.
Convatec Dominican Republic, Inc.: FDA-registered device maker in Haina San Cristobal, Dominican Republic, 9 510(k) clearances
Convatec Dominican Republic, Inc. is registered with the FDA (registration 9618003) in Haina San Cristobal, Dominican Republic. It lists 16 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9618003
- FEI number
- 3003264198
- Address
- CARRETERA SANCHEZ, KM. 18.5 PARQUE INDUSTRIAL ITABO, S.A., Buildings 8A, 23, 29, 30, Haina San Cristobal, Dominican Republic, 91000
- Owner or operator
- ConvaTec (2241599)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 1, 1981
- Registered through
- 2026
- Brand names listed
- ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive, ACTIVE LIFE One-Piece Closed-End Pouch, ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier, ACTIVE LIFE One-Piece Urostomy Pouch Durahesive, AQUACEL Ag Advantage Surgical, AQUACEL Ag Advantage Surgical SP, AQUACEL Ag Surgical, AQUACEL Ag Surgical SP and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 28, 2025 | K243228 | Flexi-Seal AIR (with ENFit Connector) | KNT | Substantially Equivalent | Convatec | accessdata.fda.gov |
| April 30, 2019 | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | KNT | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| March 7, 2017 | K162906 | Flexi-Seal PROTECT Fecal Management System | KNT | Substantially Equivalent | Convatec | accessdata.fda.gov |
| January 21, 2016 | K152926 | AQUACEL Ag Surgical SP Dressing | FRO | Substantially Equivalent | Convatec Limited | accessdata.fda.gov |
| July 21, 2015 | K150350 | Flexi-Seal Signal Fecal Management System | KNT | Substantially Equivalent | Convatec, Ltd. | accessdata.fda.gov |
| December 16, 2009 | K091034 | AQUACEL AG SURGICAL | FRO | Substantially Equivalent | Convatec | accessdata.fda.gov |
| August 26, 1983 | K832299 | VISI-FLOW IRRIGATOR | EXD | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons | accessdata.fda.gov |
| June 16, 1981 | K811240 | SUR-FIT LOOP OSTOMY O.R. SET | EXB | Substantially Equivalent | E. R. Squibb & Sons, Inc. | accessdata.fda.gov |
| June 2, 1981 | K811160 | SUR-FIT IRRIGATION SLEEVE | EXD | Substantially Equivalent | E. R. Squibb & Sons, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Bag, Urinary, Ileostomy
- All makers of Dressing, Wound, Drug
- All makers of Ostomy Care Kit
Updated March 28, 2025. 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.