Data / Medical devices / Germany / Bluepoint Medical GMBH & Co. KG
Bluepoint Medical GMBH & Co. KG: FDA-registered device maker in Selmsdorf Mecklenburg-Western Pomerania, Germany, 2 510(k) clearances
Bluepoint Medical GMBH & Co. KG is registered with the FDA (registration 3012834717) in Selmsdorf Mecklenburg-Western Pomerania, Germany. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 18, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012834717
- Address
- An der Trave 15, Selmsdorf Mecklenburg-Western Pomerania, Germany, 23923
- Owner or operator
- Bluepoint Medical GmbH & Co. KG (10054095)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 9, 2017
- Registered through
- 2026
- Brand names listed
- 5514182 Gas exhaust line, 1 m/3.3 ft, 5514183 Gas exhaust line, 0.18 m/7 in, 5514184 Gas exhaust line, 2 m/6.6 ft, Airway Gas Sampling Products, NELLCOR FLEXMAX Flexible SpO2 Sensor, Reusable, NELLCOR FLEXMAX-HC Flexible SpO2 Sensor, Reusable, Homecare, NELLCOR FLEXMAX-P Flexible SpO2 Sensor, Reusable, Small, NELLCOR FLEXMAX-P-HC Flexible SpO2 Sensor, Reusable, Homecare, Small
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Contract manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2019 | K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric | CCK | Substantially Equivalent | Bluepoint Medical GmbH & Co. KG | accessdata.fda.gov |
| February 6, 2017 | K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) | DQA | Substantially Equivalent | Bluepoint Medical GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Analyzer, Gas, Oxygen, Gaseous-Phase
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Oximeter
- All makers of Continuous Measurement Thermometer
Updated December 18, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.