FDA Registration
Active
🇨🇭 Switzerland
Hamilton Medical AG
Reg #: 3014766741
·
FEI: 3014766741
·
Expires 2026
Products
9
Proprietary Names
20
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Hamilton Medical AG
- Registration Number
- 3014766741
- FEI Number
- 3014766741
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Parc lndustrial Vial 10
- City
- Domat / Ems Graubunden
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K193228
Owner / Operator
- Firm Name
- Hamilton Medical AG
- Operator Number
- 10059168
- Address
- Via Crusch 8
- City
- Bonaduz
- State
- Graubunden
- Postal Code
- 7402
- Country
- CH
- Correspondent
- Annemarie Hoeft
US Agent
- Business Name
- Hamilton Medical, Inc.
- Contact Name
- Kyle Hofer
- Address
- 201 Edison Way
- City
- Reno
- State
- NV
- ZIP
- 89502
- Country
- US
- [email protected]
- Phone
- 800 4516478 ext. 6004
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2022-07-27 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2020-05-13 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2019-06-18 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2019-06-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-10-24 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2019-10-24 |
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2019-06-18 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2021-07-22 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2021-02-19 |
Proprietary Names
Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN 260206
Breathing circuit set, coaxial, single use, adult/pediatric PN 260167, PN 260168, PN 260145, PN 260144, PN 260087
Breathing circuit sets, dual limb, single use, neonatal PN 260180, PN 260182, PN 260169, PN 260170
Breathing circuit set, coaxial, single use, adult/pediatric PN 260207, PN 260239, PN 260240, PN 260257
Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244
HAMILTON-G5
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON-C3
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON-T1, HAMILTON-C1
HAMILTON-MR1
HAMILTON-C2
HAMILTON-C6
IntelliCuff
Ventilair II Medical Air Compressor
Expiratory valve set , reusable, PN 161175, PN 161188, PN 151972, PN 160245
Expiratory valve set , single use, PN 160176, PN 161186, PN 161189, PN 950158
Flow sensor, single use, neonatal PN 260179, PN 260177, PN 155500
Flow sensor, single use, neonatal/adult/pediatric PN 282049
Flow sensor, single use, adult/pediatric PN 282051, PN 281637, PN 950185
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device