FDA Registration
Active
🇪🇪 Estonia
RAUMEDIC Estonia AS
Reg #: 3008264255
·
FEI: 3008264255
·
Expires 2026
Products
15
Proprietary Names
72
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- RAUMEDIC Estonia AS
- Registration Number
- 3008264255
- FEI Number
- 3008264255
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kadaka tee 46a
- City
- Tallinn Harjumaa
- Country
- EE
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 |
|---|---|---|---|---|---|
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2014-10-29 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2026-02-05 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2015-07-23 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2015-07-23 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2015-07-23 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2015-07-23 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2015-07-23 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2015-07-23 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2015-07-23 |
| Computer, Oxygen-Uptake | BZL | Class 2 | Anesthesiology | No | 2015-07-23 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2011-01-04 |
| 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 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2016-03-16 |
Proprietary Names
Compact canister, reusable
Gasket for Top
Lid for Reusable Compact Canister
Grid for compact canister
MAJ-1607/1608
Water Trap, D-fend (+)
NMT - Sensor Cable, 3.3m/11 ft.
NMT - Regional Block Adapter, 0.5m/1.5 ft.
D-Fend Water Trap, Black, 10/pkg
ADU Manual Bag Tube
Patient Spirometry Kit, Adult, 50 kits/pkg
Anesthesia Gas Sampling Line, Disposable, 2m/7ft, 100/pkg
Exhaust line, 2m/7ft
ASSY-HKI, ADU Manual Bag Tube for China, Accessory - Buy
Anesthesia Gas Sampling Line, Disp. M/F Luer, 3m/10ft 10/pkg
Anesthesia Gas Sampling Line, Disposable, 3m/10ft, 100/pkg
Spirometry Tube, Disposable, Yellow, 3m/10 ft, pkg of 5 pcs
Exhaust Line for Gas Return or Scavenging, Disp., 2m/7ft
Pedi-lite+ Spirometry Sensor, Disposable, 50/pkg
Exhaust Line with Coulter Fitting, Disposable, 1m/41in
Disposable anestesia gas sampling line, OEM
Anesthesia Gas Sampling Line Disp. M/M Elbow, 3m/10ft 10/pkg
Exhaust Line with Coulter Fitting, Disposable, 0.18m/7in
Disposable CO2 Sampling Line, M/M Luer, 3m/10ft, 10/pkg
Anesthesia Gas Sampling Line, Disp. M/M Elbow, 2m/7ft 10/pkg
Spirometry Tube, Disposable, Green, 3m/10 ft, pkg of 5 pcs
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
Disposable anesthesia gas sampling line, 2.5m, M/M Luer
Disposable Spirometry Tube, Yellow, 2m/7ft, 5/pkg
Anesthesia Gas Sampling Line, Disposable, 6m/20ft, 5/pkg
Patient Spirometry Kit, Pediatric, 50/pkg
Patient Spirometry Kit, Humid Conditions, 2m/7ft, 20/pkg
Datascope SAMPLE LINE,PE/PVC,1.2mm,3m
Patient Spirometry Kit for ICU, 35 kits/pkg
Patient Spirometry Kit, Humid Conditions, 3m/10ft, 20/pkg
Nasal Sampling Line, Large Adult, 2m/7ft, 10/pkg
Nasal Sampling Line, Adult, 2m/7ft, 10/pkg
Patient Spirometry Kit, Pediatric, 50 kits/pkg
Nasal Sampling Line, Pediatric, 2m/7ft, 10/pkg
D-lite+ Sensor, Disposable, Humid Conditions, 50/pkg
Disposable CO2 Sampling Line, M/M Luer, 2m/7ft, 10/pkg
Anesthesia Gas Sampling Line, Disposable, 3m/10ft, 10/pkg
Anesthesia Gas Sampling Line, Disposable, 2m/7ft, 10/pkg
Pedi-lite+ Patient Spirometry Kit, 3m/10ft
GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 2M/7FT
SPIROMETRY TUBE, DISPOSABLE, 3M/10FT
SPIROMETRY TUBE, DISPOSABLE, 6M/20FT
SPIROMETRY TUBE, DISPOSABLE, 2M/7FT
Pedi-lite+ sensor, disposable, Pediatric,
D-lite+ sensor, disposable, Adult
Pedi-lite+ Patient Spirometry Kit, 2m/7ft
GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 6M/20FT
GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 3M/10FT
GAS SCAVENGER 10FT TGB W/CPLG
NIBP Adult hose, black, 3 m/10 ft
NIBP Adult hose, black, 1.8 m/6 ft
NIBP Adult hose, black, 6m/20 ft
ASSY-HKI, CO2 Sampling Line, Multipatient, 2m, 10/pkg. Accessory - buy
ASSY-HKI, CO2 Sampling Line, Multipatient, 3m, 10 pkg, Accessory - buy
ASSY-HKI, Anesthesia Gas Sampling Line, Elbow, Mulitpatien, 3, 10/pkg, Accessory-buy
ASSY-HKI, Anesthesia Gas Sampling Line, Elbow, Mulitpatient, 2m, 10/pkg, Accessory - buy
KIT PVC B-LINE SAMPLE 50/CS
ADAPTER AIRWARY STR 150/CASE
KIT B-LINE 10FT .8UM FLTE/STR
KIT PVC B-LINE STRAIGHT 50/CS
KIT PVC B-LINE W/ELBOW 50/CS
KIT B-LINE 10FT (50 PCS/BAG)
KIT B-LINE 10FT W/ELBOW ADPTR
KIT B-LINE 10FT W/STR ADAPTER
KIT B-LINE 10FT .8UM FILTER
Water Trap, Mini D-fend
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)