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Sign in to claim this brandPlastiflex Group NV
Belgium·BE-MF-000008049
Last updated September 18, 2026
About
Welcome to the Plastiflex Group, world leader in designing, developing and manufacturing of custom made tubing systems. Our solutions meet all relevant industry regulations and quality standards.
From the manufacturer's own website. Source
What Plastiflex Group NV makes
The company manufactures single-use and reusable ventilator breathing circuits, including standard and reusable tubing systems for mechanical ventilation and CPAP therapy. Examples include single-limb and dual-limb circuits, such as the Classic FL 15, Atemschlauch for CPAP, and the Hybernite RT 2000, as well as transparent and color-coded reusable models like the Classic 19 Transparent and Classic RT 12 White.
These products are classified under EU Medical Device Regulations as Class I or Class II/IIa devices, with regulatory listings in the EUDAMED database, FDA’s 510(k) and UDI systems. The company is based in Belgium and operates within these global regulatory frameworks for medical tubing systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Belgium
- Address
- 13, Buntjesstraat , Beringen, Belgium
- Website
- www.plastiflex.com
- —
- —
- [email protected]
- Phone
- +32 11 43 58 00
- PRRC Contact
- Piet Gruwez
- EUDAMED SRN
- BE-MF-000008049
- FDA FEI Number
- —
- DUNS Number
- 371165452
Catalogue (146)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Classic RT | Ultralite 15 x 1000 Blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite 15 x 1200 Blue | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 1830 White | FDA UDI | Class I | Active |
| Classic RT | Classic RT 12x500 Blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 600 White | FDA UDI | Class I | Active |
| Clasic Rt | Classic RT 19 x 500 Blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 400 Blue | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 1830 Blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15x700 blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 2100 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite 15 x 700 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 300 Blue | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 300 White | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 1500 Blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 2400 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite 15 x 1200 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 300 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite 15 x 800 White | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 1000 White | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 400 Blue | FDA UDI | Class I | Active |
| Hybernite | Sleepbox Heated Tube | EUDAMEDFDA UDI | Class II | Active |
| Classic RT | Ultralite 15 x 1200 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 2400 White | FDA UDI | Class I | Active |
| Hybernite RT | RT 114 Convenience kit | FDA UDI | Class II | Active |
| Classic RT | Ultralite Mini 15 x 2000 Blue | FDA UDI | Class I | Active |
| Classic RT | Classic RT19 x 300 Blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 300 White | FDA UDI | Class I | Active |
| Hybernite RT | Hybernite RT 15 ins | EUDAMEDFDA UDI | Class II | Active |
| Classic RT | Classic RT 19 x 1200 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 500 Blue | FDA UDI | Class I | Active |
| Hybernite RT | Hybernite RT 15 ex | EUDAMEDFDA UDI | Class II | Active |
| Classic RT | Ultralite Mini 15 x 1830 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 600 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 500 White | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 800 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 2100 White | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 800 Blue | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 500 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite 15 x 1000 White | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 450 Blue | FDA UDI | Class I | Active |
| Classic RT | Classic RT 19 x 600 Blue | FDA UDI | Class I | Active |
| Classic RT | Ultralite Mini 15 x 800 White | FDA UDI | Class I | Active |
| Classic 19 CPAP Tubing | HUE19018GT0SSGGK | EUDAMED | Class IIa | Active |
| Hybernite Rainout Control System | K100104 | FDA 510(k) | Class II | Active |
| Hybernite RT 3000 (Dual Limb) | HEN12041BT1PRWGK | EUDAMED | Class IIa | Active |
| - Hybernite ROC EU | HHE19018WT0ECBCK | EUDAMED | Class IIa | Active |
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