FDA Registration
Active
🇪🇪 Estonia
D-Fend Water Trap, Black, 10/pkg
Reg #: 3008264255
·
FEI: 3008264255
·
Expires 2025
Products
10
Proprietary Names
36
Establishment Types
1
Classifications
10
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
- K051092
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, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2010-03-12 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2010-03-12 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2010-03-12 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2010-03-12 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2010-03-12 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2010-03-12 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2010-03-12 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2010-03-12 |
| Computer, Oxygen-Uptake | BZL | Class 2 | Anesthesiology | No | 2010-03-12 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2010-03-12 |
Proprietary Names
D-Fend Water Trap, Black, 10/pkg
ADU Manual Bag Tube
Datascope SAMPLE LINE,PE/PVC,1.2mm,3m
OEM-ITEM, Drager Gas Sampling Line, PE/PVC, 1.2mm/2.8mm, male/male, Luer lock, pkg 10pcs
Spirometry Tube, Disposable, Yellow, 6m/20 ft, pkg of 5 pcs
Patient Spirometry Kit, Adult, 50 kits/pkg
D-lite+ Sensor, Disposable, Humid Conditions, 50/pkg
Anesthesia Gas Sampling Line, Disposable, 2m/7ft, 100/pkg
Exhaust line, 2m/7ft
Nasal Sampling Line, Large Adult, 2m/7ft, 10/pkg
Anesthesia Gas Sampling Line, Disposable, 2m/7ft, 10/pkg
Anesthesia Gas Sampling Line Disp. M/M Elbow, 3m/10ft 10/pkg
Exhaust Line with Coulter Fitting, Disposable, 0.18m/7in
ASSY-HKI, ADU Manual Bag Tube for China, Accessory - Buy
Disposable anesthesia gas sampling line, 2.5m, M/M Luer
Patient Spirometry Kit, Pediatric, 50 kits/pkg
Spirometry Tube, Disposable, Yellow, 3m/10 ft, pkg of 5 pcs
Exhaust Line for Gas Return or Scavenging, Disp., 2m/7ft
Anesthesia Gas Sampling Line, Disp. M/M Elbow, 2m/7ft 10/pkg
Patient Spirometry Kit, Pediatric, 50/pkg
Disposable anestesia gas sampling line, OEM
Nasal Sampling Line, Adult, 2m/7ft, 10/pkg
Spirometry Tube, Disposable, Green, 3m/10 ft, pkg of 5 pcs
Pedi-lite+ Spirometry Sensor, Disposable, 50/pkg
Exhaust Line with Coulter Fitting, Disposable, 1m/41in
Patient Spirometry Kit for ICU, 35 kits/pkg
Nasal Sampling Line, Pediatric, 2m/7ft, 10/pkg
Anesthesia Gas Sampling Line, Disposable, 6m/20ft, 5/pkg
Disposable CO2 Sampling Line, M/M Luer, 2m/7ft, 10/pkg
Disposable CO2 Sampling Line, M/M Luer, 3m/10ft, 10/pkg
Anesthesia Gas Sampling Line, Disposable, 3m/10ft, 100/pkg
Anesthesia Gas Sampling Line, Disposable, 3m/10ft, 10/pkg
Patient Spirometry Kit, Humid Conditions, 3m/10ft, 20/pkg
Disposable Spirometry Tube, Yellow, 2m/7ft, 5/pkg
Patient Spirometry Kit, Humid Conditions, 2m/7ft, 20/pkg
Anesthesia Gas Sampling Line, Disp. M/F Luer, 3m/10ft 10/pkg
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)