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
Phone
424 2718169

Products

Device Name Product Code
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
Analyzer, Gas, Oxygen, Gaseous-Phase CCL
Spirometer, Monitoring (W/Wo Alarm) BZK
Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
Computer, Oxygen-Uptake BZL
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ

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)