FDA Registration
Active
🇨🇭 Switzerland
SCHILLER AG
Reg #: 8030978
·
FEI: 3002808182
·
Expires 2026
Products
15
Proprietary Names
21
Establishment Types
4
Classifications
14
Registration Details
- Registration Name
- SCHILLER AG
- Registration Number
- 8030978
- FEI Number
- 3002808182
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ALTGASSE 68
- City
- BAAR Zug
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K053369
Owner / Operator
- Firm Name
- SCHILLER AG
- Operator Number
- 8030978
- Address
- ALTGASSE 68, --
- City
- BAAR, ZG
- State
- Zug
- Postal Code
- 6341
- Country
- CH
US Agent
- Business Name
- SCHILLER AMERICAS, INC.
- Contact Name
- Ramon Martorell
- Address
- 10903 NW 33RD ST
- City
- Doral
- State
- FL
- ZIP
- 33172
- Country
- US
- [email protected]
- Phone
- 305 5911121
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2017-03-28 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2017-07-03 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2023-07-13 |
| LOS | No | 2005-11-10 | |||
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 1981-07-10 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2017-07-24 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2017-01-05 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2016-12-21 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2017-07-03 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2007-03-27 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2007-03-27 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2017-03-28 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2020-08-07 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2020-08-07 |
| Aid, Cardiopulmonary Resuscitation | LIX | Class 2 | Cardiovascular | No | 2020-08-07 |
Proprietary Names
Scale
MEDILOG DARWIN HOLTER ANALYSIS
medilog DARWIN2 U
ARGUS PB-3000
CARDIOVIT AT-1c, AT-2c, AT-2 plus
SPIROVIT SP-250
Cardiovit FT-1
Thermal paper
CARDIOVIT AT-10 plus (SEMA200)
Mouth piece
CARDIOVIT CS-200 Excellence
DS-20
CARDIOVIT AT-102
CARDIOVIT AT-101
medilogAR U
BP-200 plus
Scanner
ARGUS PB-1000; ARGUS PB-2000
TEMPUS LS - MANUAL
CARDIOVIT AT-102 G2
CARDIOVIT AT-180
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor