DGDA Certifies KBMED Products, Advancing ISO 80369-3 Implementation
- KL KBMED
- Sep 8
- 2 min read
Building on its earlier announcement of Securing DGDA certification in Bangladesh, KBMED, a U.S.-based leader in enteral feeding solutions, now underscores the importance of this approval as a milestone in advancing international enteral device safety standards.
The ENFit®-compliant Silicone Stomach Tubes and Enteral Feeding Syringes registered with the Directorate General of Drug Administration (DGDA) represent a pivotal step in the global adoption of ISO 80369-3 standards, which are designed to prevent tubing misconnections and improve patient safety in enteral feeding.With this certification, KBMED’s enteral feeding products have been granted a five-year medical device registration license, as well as approved import permits and letters of credit (L/Cs). These approvals not only validate KBMED’s commitment to compliance but also provide the framework for its strategic entry into the Bangladesh market later this year. |
“Connection errors remain one of the most serious risks in enteral nutrition therapy,” said Ruffy L., Manager of KBMED. “As a founding member of GEDSA, KBMED has supported more than 20 countries in their transition to ENFit® standards. Our successful registration in Bangladesh underscores both the clinical value and regulatory strength of our enteral products.” |
Registered Products Now Approved for Bangladesh Market:✅Silicone Enteral Feeding Tubes and ENFit® Enteral Syringes.In addition to these core offerings, KBMED also provides: ✅ ENFit® Conversion Kits – for upgrading legacy systems ✅ Pump-Compatible Feeding Sets ✅ Pre-filled Syringes & Pediatric Systems ✅ A Full Suite of ENFit® Accessories |
In support of a recent GEDSA-led initiative to recruit qualified OEM manufacturers for ENFit® accessories, KBMED has joined the effort, offering precision-engineered components tailored to partners’ specific design and clinical requirements. |
Currently, KBMED is providing ENC1 and ENC2 connectors for compact feeding system applications in the United States, ENC4 connectors for gastric tube applications in Mexico, and bulk-pack ENFit® syringes for fast-growing demand in Brazil. These projects demonstrate KBMED’s ability to deliver region-specific solutions while maintaining global quality standards.
With scalable production capacity and flexible OEM services, KBMED continues to meet the increasing international demand for ENFit® components, supporting safer enteral nutrition delivery across diverse clinical environments.🏅 |
