RAUMEDIC Estonia AS

FDA Device Registration & Listing · Tallinn Harjumaa, EE · Registration 3008264255

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008264255
FEI Number
3008264255
Entity Name
RAUMEDIC Estonia AS
City/State/Country
Tallinn Harjumaa, EE
Establishment Address
Kadaka tee 46a, Tallinn Harjumaa EE 12915, EE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
RAUMEDIC Estonia AS (Owner Number: 10031831)
Owner / Operator Contact Address
Kadaka tee 46a, Tallinn, EE-37 EE 12915, EE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2014-10-29
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2026-02-05
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2015-07-23
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2015-07-23
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2015-07-23
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2015-07-23
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2015-07-23
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2015-07-23
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2015-07-23
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2015-07-23
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2011-01-04
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2010-03-12
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2010-03-12
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2010-03-12
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2010-03-12
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2010-03-12
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2010-03-12
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2010-03-12
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2010-03-12
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2010-03-12
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2010-03-12
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-09-27
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2024-09-27
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-09-27
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-09-27
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-09-27
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2024-09-27
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2024-09-27
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2024-09-27
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2024-09-27
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2024-09-27
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2024-09-27
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2012-08-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2016-03-16
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2012-08-23
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2011-01-04

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Business: Qserve Group US Inc Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

RAUMEDIC Estonia AS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812140 3M Company BIRD MEAN AIRWAY PRESSURE MONITOR 1981-08-20
K040917 Philips Medizin Systeme Boeblingen GmbH PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B 2004-04-29
K072469 Digiflo, Inc. DIGIFLO CONCENTRATOR ANALYZER 2008-01-03
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008264255. Last updated year: 2026. Please use registration number 3008264255 when referencing this establishment in official correspondence.
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