FDA Registration
Active
🇨🇭 Switzerland
HAMILTON MEDICAL AG
Reg #: 3001421318
·
FEI: 3001421318
·
Expires 2026
Products
7
Proprietary Names
16
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- HAMILTON MEDICAL AG
- Registration Number
- 3001421318
- FEI Number
- 3001421318
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA CRUSCH 8
- City
- BONADUZ Graubunden
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K181216
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. 210
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2019-10-24 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-10-24 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2019-10-24 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2021-02-19 |
| 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 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2022-07-27 |
Proprietary Names
HAMILTON-T1, HAMILTON-C1
HAMILTON-C6
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
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
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-C3
HAMILTON-MR1
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility