This page includes the latest FDA filings for Plastiflex Healthcare Division Of Plastiflex Group N V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008342612 |
| FEI Number | 3008342612 |
| Name | Dongguan Plastiflex Hose Technology Ltd |
| Owner & Operator | Plastiflex Healthcare Division of Plastiflex Group NV |
| Contact Address | Buntjesstraat 13 Paal Beringen BE-VLI Limburg B-3583 BE |
| Official Correspondent |
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| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Qiaozi Industrial District, Changping Town Dongguan City Guangdong, 523752 CN |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3008331339 |
| FEI Number | 3008331339 |
| Name | Jennifer Hadfield |
| Owner & Operator | Plastiflex Healthcare Division of Plastiflex Group NV |
| Contact Address | Buntjesstraat 13 Paal Beringen BE-VLI Limburg B-3583 BE |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1 Boston Pl Ste 2600 Boston, MA 02108 US |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
| Registration Number | 3003240001 |
| FEI Number | 3003240001 |
| Name | Plastiflex North Carolina |
| Owner & Operator | Plastiflex Healthcare Division of Plastiflex Group NV |
| Contact Address | Buntjesstraat 13 Paal Beringen BE-VLI Limburg B-3583 BE |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2101 Sherrill Dr Statesville, NC 28625 US |
Device Company | Device | Date |
|---|---|---|
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 3100 | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 3000 | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 2100, HFN19022BT1SSWGK | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 2000, HEN1504BT1SSWGK | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 12mm, HFN12025BT1PRWGK | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 12mm, HEN12041BT1PRWGK | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 1100, HFN15023BT1SSWGK | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 1000, HEN19038BT1SSWGK | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 3100 | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 3000 | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 2100, HFN19022BT1SSWGK | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 2000, HEN1504BT1SSWGK | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 12mm, HFN12025BT1PRWGK | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 12mm, HEN12041BT1PRWGK | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 1100, HFN15023BT1SSWGK | 2016-08-23 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite RT 1000, HEN19038BT1SSWGK | 2016-08-23 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | IntelliPAP Heated Tube | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite Rainout Control System | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite HBT300 US version HRU19018BT0ECBGK | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE POWERPAL HSNSWHYBK00NNNGI | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE INTELLIPAP HBT in sleeve (15) HRU19018BT0032SI | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE HBT2300 01-15404013000095 HU19018BT0ECBCK | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE 3B replace Tube (25) HRU19018BT0033GI | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE 3B ROC Kit w/power pal (15) HHU19018BT0033CK | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | 3B Comfortline Heated Breathing Tube Kit | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | IntelliPAP Heated Tube | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite Rainout Control System | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Hybernite HBT300 US version HRU19018BT0ECBGK | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE POWERPAL HSNSWHYBK00NNNGI | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE INTELLIPAP HBT in sleeve (15) HRU19018BT0032SI | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE HBT2300 01-15404013000095 HU19018BT0ECBCK | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE 3B replace Tube (25) HRU19018BT0033GI | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | HYBERNITE 3B ROC Kit w/power pal (15) HHU19018BT0033CK | 2010-04-19 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | 3B Comfortline Heated Breathing Tube Kit | 2010-04-19 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Ventilator/CPAP Tube | 2010-03-26 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | UltraCair Breathing Tube | 2010-03-26 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | Classic 19 Sunset HUU19018GT2045GI | 2010-03-26 |
Jennifer Hadfield [Plastiflex Healthcare Division of Plastiflex Group NV] | CLASSIC US 19x6 Feet Single-42 HUU19018GT0SSNGK | 2010-03-26 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Ventilator/CPAP Tube | 2010-03-26 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | UltraCair Breathing Tube | 2010-03-26 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | Classic 19 Sunset HUU19018GT2045GI | 2010-03-26 |
Dongguan Plastiflex Hose Technology Ltd [Plastiflex Healthcare Division of Plastiflex Group NV] | CLASSIC US 19x6 Feet Single-42 HUU19018GT0SSNGK | 2010-03-26 |