FDA Registration
Active
🇨🇳 China
Dongguan Plastiflex Hose Technology Ltd
Reg #: 3008342612
·
FEI: 3008342612
·
Expires 2026
Products
3
Proprietary Names
13
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- Dongguan Plastiflex Hose Technology Ltd
- Registration Number
- 3008342612
- FEI Number
- 3008342612
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Qiaozi Industrial District, Changping Town
- City
- Dongguan City Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Plastiflex Healthcare Division of Plastiflex Group NV
- Operator Number
- 10031967
- Address
- Buntjesstraat 13
- City
- Paal Beringen
- State
- Limburg
- Postal Code
- B-3583
- Country
- BE
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2022-02-07 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2026-01-16 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2010-03-26 |
Proprietary Names
TUB06HPR Heated CPAP Tube
Hybernite RT 3000 (Dual Limb), HEN12041BT1PRWGK
Hybernite RT 2100 (Single Limb), HFN15023BT1SSWGK
Hybernite RT 3100 (Single Limb), HFN12025BT1PRWGK
Hybernite RT 1100 (Single Limb), HFN19022BT1SSWGK
Hybernite RT 1000 (Dual Limb), HEN19038BT1SSWGK
Hybernite RT 2000 (Dual Limb), HEN15040BT1SSWGK
Hybernite RT 114 Convenience kit HFN19022BT1STWGO
Heater, breathing system W/WO controller (not humidifier or nebulizer)
Hybernite ROC US HHU19018WT0ECBCK
Replacement Comfortline Heated Tubing HRU19018WT0033GI
Comfortline Heated Tubing HHU19018WT0033CK
Hybernite HBT White HRN19018WT0ECWGC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)