FDA Registration
Active
🇸🇪 Sweden
Frohe Sweden AB
Reg #: 3005135175
·
FEI: 3005135175
·
Expires 2026
Products
7
Proprietary Names
5
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- Frohe Sweden AB
- Registration Number
- 3005135175
- FEI Number
- 3005135175
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- STROMFALLSVAGEN 4
- City
- Tyreso
- Country
- SE
Owner / Operator
- Firm Name
- Masimo Corporation
- Operator Number
- 9075000
- Address
- 52 Discovery
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Mathew - Jimenez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-01-31 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2013-01-31 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2013-01-31 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2013-01-31 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2013-01-31 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2013-01-31 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2013-01-31 |
Proprietary Names
IRMA - Infrared Mainstream Gas Analyzer
ISA OR+
ISA AX+
ISA CO2
EMMA Airway adapter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)