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Plastiflex 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +32 11 43 58 00
PRRC Contact: Piet Gruwez
EUDAMED SRN: BE-MF-000008049
FDA FEI Number: —
DUNS Number: 371165452

Catalogue (145)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Classic FL 15	HWN15018GT0WWGGI	EUDAMED	Class IIa	Active
Classic 19 White 22F/22F 0.60m	HUN19D60WT0SSWBB	EUDAMED	Class IIa	Active
Atemschlauch f�r CPAP Glattes Lumen, grau (180 cm, 22 mm �)	HUE19018GT0016GI	EUDAMED	Class IIa	Active
Hybernite RT 2000 (Dual Limb)	HEN15040BT1SSWGK	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 0.30m	HVN12D30WT0PPWBB	EUDAMED	Class IIa	Active
Classic 15 White	HUN15018WT0SSWGI	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 0.50m	HVN12D50WT0PPWBB	EUDAMED	Class IIa	Active
S.Box 15MM STANDARD TUBE STANDARD TUBE	HUE15018KT0030GI	EUDAMED	Class IIa	Active
Classic 19 Transparent	HUN19018T00WWGGI	EUDAMED	Class IIa	Active
Classic 19 White 22F/22F 0.80m	HUN19D80WT0SSWBB	EUDAMED	Class IIa	Active
Classic RT 15 Blue 15F/15F 0.40m	HVN15D40BT1RRWBB	EUDAMED	Class IIa	Active
Classic RT 12 inc Blue 15F/10F&15M 0.40m	HVN12D40BT1RPWBC	EUDAMED	Class IIa	Active
Hybernite RT 12 ins+Inc	HPN12020BT1EPWBB	EUDAMED	Class IIa	Active
Classic RT 19 White 22F/22F 1.50m	HVN19015WT0SSWBB	EUDAMED	Class IIa	Active
WM 24445 (Classic 19)	HUE19018GT0019GK	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 2.40m	HVN12024WT0PPWBB	EUDAMED	Class IIa	Active
Classic RT 19 Blue 22F/22F 0.60m	HVN19D60BT1SSWBB	EUDAMED	Class IIa	Active
Classic 15	HUE15018GT0001GI	EUDAMED	Class IIa	Active
Classic RT 12 Blue 22F/10F&15M 0.50m	HVN12D50BT1PSWBB	EUDAMED	Class IIa	Active
Classic 15 Sefam	HUE15018GT0030GI	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 2.10m	HVN12021WT0PPWBB	EUDAMED	Class IIa	Active
Classic 19 White 22F/22F 1.20m	HUN19012WT0SSWBB	EUDAMED	Class IIa	Active
Classic 15	HUE15018GT0023GI	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 1.83m	HVN12018WT0PPWBB	EUDAMED	Class IIa	Active
Hybernite RT 2100 (Single Limb)	HFN15023BT1SSWGK	EUDAMED	Class IIa	Active
Classic 19 White 22F/22F 1.50m	HUN19015WT0SSWBB	EUDAMED	Class IIa	Active
Hybernite RT 1100 (Single Limb)	HFN19022BT1SSWGK	EUDAMED	Class IIa	Active
Classic RT 19 White 22F/22F 0.90m	HVN19D90WT0SSWBB	EUDAMED	Class IIa	Active
Atemschlauch f�r CPAP Glattes Lumen, grau (180 cm, 15 mm �)	HUE15018GT0016GI	EUDAMED	Class IIa	Active
Hybernite RT 1000 (Dual Limb)	HEN19038BT1SSWGK	EUDAMED	Class IIa	Active
Classic RT 12 Blue 22F/10F&15M 0.90m	HVN12D90BT1PSWBB	EUDAMED	Class IIa	Active
Classic FL 19 HUM	HWE19018GT0051GI	EUDAMED	Class IIa	Active
Classic RT 12 inc. White 0.4m	HVN12D40WT0QQWBC	EUDAMED	Class IIa	Active
Classic FL 19	HWN19018GT0WWGGI	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 0.40m	HVN12D40WT0PPWBC	EUDAMED	Class IIa	Active
Slangenset Vivisol VIV000033	HUE19024WT0014GK	EUDAMED	Class IIa	Active
Hybernite RT 19 + Elbow	HPN19016BT1FTWBC	EUDAMED	Class IIa	Active
Classic RT 12 inc. Blue 0.4m	HVN12D40BT1QQWBC	EUDAMED	Class IIa	Active
Classic 15	HUN15018GT0WWGGI	EUDAMED	Class IIa	Active
S.Box 22MM STANDARD TUBE	HUE19018KT0030GI	EUDAMED	Class IIa	Active
Classic 15	HUE15018GT0WWGGI	EUDAMED	Class IIa	Active
WM 23962 (Classic 19)	HUE19018KT0019GK	EUDAMED	Class IIa	Active
WM 29067 prismaHYBERNITE	HPE19018WT0019GI	EUDAMED	Class IIa	Active
Classic PSL 19 Grey	HUN19018GT0SSGGL	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 1.50m	HVN12015WT0PPWBB	EUDAMED	Class IIa	Active
WM 29988 (Classic 15)	HUE15018GT0019GK	EUDAMED	Class IIa	Active
Classic 19 CPAP Tubing	HUE19018GT0023GI	EUDAMED	Class IIa	Active
Hybernite RT12 ex	HPN12016WT0EPWBB	EUDAMED	Class IIa	Active
Classic 19 White	HUN19018WT0SSWGI	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 2.00m	HVN12020WT0PPWBB	EUDAMED	Class IIa	Active

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