Data / Medical devices / Belgium / Plastiflex Healthcare Division Of Plastiflex Group NV
Plastiflex Healthcare Division Of Plastiflex Group NV: FDA-registered device maker in Paal Beringen Limburg, Belgium, 2 510(k) clearances
Plastiflex Healthcare Division Of Plastiflex Group NV is registered with the FDA (registration 3008331339) in Paal Beringen Limburg, Belgium. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 24, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008331339
- Address
- Buntjesstraat 13, Paal Beringen Limburg, Belgium, B-3583
- Owner or operator
- Plastiflex Healthcare Division of Plastiflex Group NV (10031967)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 26, 2010
- Registered through
- 2026
- Brand names listed
- Comfortline Heated Tubing HHU19018WT0033CK, Hybernite HBT White HRN19018WT0ECWGC, Hybernite ROC US HHU19018WT0ECBCK, Hybernite RT 1000 (Dual Limb), HEN19038BT1SSWGK, Hybernite RT 1100 (Single Limb), HFN19022BT1SSWGK, Hybernite RT 114 Convenience kit HFN19022BT1STWGO, Hybernite RT 2000 (Dual Limb), HEN15040BT1SSWGK, Hybernite RT 2100 (Single Limb), HFN15023BT1SSWGK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
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 24, 2016 | K151461 | Hybernite RT | BZE | Substantially Equivalent | Plastiflex Group NV | accessdata.fda.gov |
| April 14, 2010 | K100104 | HYBERNITE RAINOUT CONTROL SYSTEM | BZE | Substantially Equivalent | Plastiflex Group NV | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Updated March 24, 2016. 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.