FDA Registration
Active
🇪🇪 Estonia
D-lite+ sensor, disposable, Adult
Reg #: 3008264255
·
FEI: 3008264255
·
Expires 2025
Products
11
Proprietary Names
10
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- RAUMEDIC Estonia AS
- Registration Number
- 3008264255
- FEI Number
- 3008264255
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kadaka tee 46a
- City
- Tallinn Harjumaa
- Country
- EE
Regulatory Submissions
- 510(k) Number
- K211171
Owner / Operator
- Firm Name
- RAUMEDIC Estonia AS
- Operator Number
- 10031831
- Address
- Kadaka tee 46a
- City
- Tallinn
- State
- Harjumaa
- Postal Code
- EE 12915
- Country
- EE
- Correspondent
- Mindy McCann
US Agent
- Business Name
- Qserve Group US Inc
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2024-09-27 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2024-09-27 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2024-09-27 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2024-09-27 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2024-09-27 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2024-09-27 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2024-09-27 |
| Computer, Oxygen-Uptake | BZL | Class 2 | Anesthesiology | No | 2024-09-27 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2024-09-27 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2024-09-27 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2024-09-27 |
Proprietary Names
D-lite+ sensor, disposable, Adult
Pedi-lite+ Patient Spirometry Kit, 3m/10ft
SPIROMETRY TUBE, DISPOSABLE, 3M/10FT
GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 3M/10FT
Pedi-lite+ Patient Spirometry Kit, 2m/7ft
SPIROMETRY TUBE, DISPOSABLE, 6M/20FT
GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 6M/20FT
Pedi-lite+ sensor, disposable, Pediatric,
SPIROMETRY TUBE, DISPOSABLE, 2M/7FT
GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 2M/7FT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)