FDA Registration
Active
🇩🇪 Germany
WILAMED GMBH
Reg #: 9615827
·
FEI: 3003080079
·
Expires 2026
Products
7
Proprietary Names
19
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- WILAMED GMBH
- Registration Number
- 9615827
- FEI Number
- 3003080079
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Aurachhoehe 5 7
- City
- Kammerstein Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- WILAmed GmbH
- Operator Number
- 10033146
- Address
- Aurachhoehe 5 7
- City
- Kammerstein
- State
- Bavaria
- Postal Code
- 91126
- Country
- DE
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2017-11-13 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2019-08-13 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2017-11-13 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2026-05-28 |
| Respiratory Humidifier For Emergency Use | QOP | Class N | Unknown | No | 2021-09-03 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2011-08-29 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2025-06-27 |
Proprietary Names
Disp, 15mm, Ped, Non-Htd, Passive, Single
Disposable Active Exhalation Valve
Disposable Active Exhalation Valve (10 pack)
Disposable Swivel Passive Exhalation Port (10 pack)
Disp, 22mm, Adult, Non-Htd, Passive, single
Disp, 15mm, Ped, Non-Htd, Active, Single
Disp, 22mm, Adult, Non-Htd, Active, Single
Disp, 22mm, Adult, Non-Htd, Passive, 10 pack
Disp, 15mm, Ped, Non-Htd, Passive, 10 pack
Disp, 15mm, Ped, Non-Htd, Active, 10 pack
Disposable Swivel Passive Exhalation Port
Disp, 22mm, Adult, Non-Htd, Active, 10 pack
Clearline
Airlife DuoTherm Humidification System
AirLife DuoTherm® Temperature Probe, Reusable, 180 cm
AirLife DuoTherm® Reusable Dual-Limb Heated Wire Adapter
AirLife DuoTherm® Reusable Single-Limb Heated Wire Adapter
AirLife DuoTherm® Heated Humidifier, 110-120V
AirLife DuoTherm® Temperature Probe, Reusable, 160 cm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device