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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 (146)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Classic RT 12 White 10F&15M/10F&15M 2.00m	HVN12020WT0PPWBB	EUDAMED	Class IIa	Active
CPAP Tubing Sefam	HUE19018GT0030GI	EUDAMED	Class IIa	Active
WM 29083 prismaHYBERNITE	HPE15018WT0019GI	EUDAMED	Class IIa	Active
Classic FL 15 HUM	HWE15018GT0051GI	EUDAMED	Class IIa	Active
Classic RT 12 White 10F&15M/10F&15M 0.90m	HVN12D90WT0PPWBB	EUDAMED	Class IIa	Active
Hybernite RT 12 ins	HPN12016BT1ETWBC	EUDAMED	Class IIa	Active
Classic RT	Classic RT 19 x 1200 Blue	FDA UDI	Class I	Active
Hybernite	3BCL 1010 3B ComfortLine	FDA UDI	Class II	Active
Hybernite RT	Hybernite RT 19 ins	EUDAMEDFDA UDI	Class II	Active
Classic RT	Ultralite Mini 15 x 450 White	FDA UDI	Class I	Active
Classic RT	Classic RT 19 x 700 White	FDA UDI	Class I	Active
Classic	Classic 19 Black 1830	FDA UDI	Class I	Active
Classic RT	Ultralite 15 x 1500 White	FDA UDI	Class I	Active
Classic RT	Classic RT 19 x 400 White	FDA UDI	Class I	Active
Hybernite RT	Hybernite RT 12 ex	EUDAMEDFDA UDI	Class II	Active
Classic RT	Classic RT 19 x 600 White	FDA UDI	Class I	Active
Hybernite	Comfortline 3B	FDA UDI	Class II	Active
Classic RT	Ultralite Mini 15 x 2100 Blue	FDA UDI	Class I	Active
Hybernite	Hybernite ROC US	FDA UDI	Class II	Active
Hybernite	Hybernite HBT White	EUDAMEDFDA UDI	Class II	Active
Classic RT	Ultralite Mini 15 x 2000 White	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15 x 1830 Blue	FDA UDI	Class I	Active
Hybernite	HBT IntelliPAP	FDA UDI	Class II	Active
Hybernite RT	Hybernite RT 19 ex	FDA UDI	Class II	Active
Classic	Classic 19 US	EUDAMEDFDA UDI	Class I	Active
Classic RT	Classic RT 19 x 1000 Blue	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15 x 2000 White	FDA UDI	Class I	Active
Hybernite RT	RT 114	EUDAMEDFDA UDI	Class II	Active
Classic RT	Classic RT 19 x 1500 White	FDA UDI	Class I	Active
Classic RT	Classic RT 19 x 700 Blue	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15 x 1830 White	FDA UDI	Class I	Active
Hybernite	ComfortLine Heated Tubing	FDA UDI	Class II	Active
Classic RT	Classic RT 12x900 Blue	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15x700 White	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15 x 800 Blue	FDA UDI	Class I	Active
Classic RT	Ultralite 15 x 1500 White	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15 x 400 White	FDA UDI	Class I	Active
Classic RT	Classic RT 19 x 450 Blue	FDA UDI	Class I	Active
Hybernite RT	Hybernite RT 12 ins	EUDAMEDFDA UDI	Class II	Active
Hybernite RT	Hybernite RT 12 ins+Inc	EUDAMEDFDA UDI	Class II	Active
Hybernite	Hybernite HBT US	FDA UDI	Class II	Active
Classic RT	Ultralite Mini 15 x 450 White	FDA UDI	Class I	Active
Hybernite	Hybernite ROC US	FDA UDI	Class II	Active
Classic RT	Ultralite Mini 15 x 2400 Blue	FDA UDI	Class I	Active
Hybernite	Replacement Comfortline Heated Tubing	FDA UDI	Class II	Active
Hybernite	Hybernite HBT white US	FDA UDI	Class II	Active
Classic RT	Ultralite 15 x 1000 White	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15 x 400 White	FDA UDI	Class I	Active
Classic RT	Ultralite Mini 15 x 1830 White	FDA UDI	Class I	Active
Classic RT	Ultralite 15 x 1500 Blue	FDA UDI	Class I	Active

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