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
Phone
800 4516478 ext. 6004

Products

Device Name Product Code
Set, Tubing And Support, Ventilator (W Harness) BZO
Ventilator, Continuous, Facility Use CBK
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
Oximeter DQA
Mixer, Breathing Gases, Anesthesia Inhalation BZR
Cuff, Tracheal Tube, Inflatable BSK
Compressor, Air, Portable BTI
Tubing, Pressure And Accessories BYX

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