Data / Medical devices / Bulgaria / Medeia Group Ltd
Medeia Group Ltd: FDA-registered device maker in Sofia Sofia-Grad, Bulgaria, 8 510(k) clearances
Medeia Group Ltd is registered with the FDA (registration 3007048291) in Sofia Sofia-Grad, Bulgaria. It lists 14 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 28, 2023. 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
- 3007048291
- Address
- 17 Vejen Str., Sofia Sofia-Grad, Bulgaria, 1421
- Owner or operator
- Medeia Group Ltd (10045005)
- Roles
- Manufacturer
- First device listed
- September 11, 2013
- Registered through
- 2026
- Brand names listed
- ANSHA - QHRV1, BrainView, BrainView QEEG, CardioView, Critical Care Assessment, NeuralScan System, QBioscan, QHRV1 - Health Assessment System and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| January 28, 2023 | K212684 | BrainView QEEG Software | OLU | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| March 17, 2020 | K192753 | NeuralScan System | GWQ | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| January 15, 2020 | K191266 | VitalScan ANS | JOM | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| April 29, 2016 | K152973 | Dyna-Vision Telemonitoring System | MHX | Substantially Equivalent | Techmedic Development International B.V. | accessdata.fda.gov |
| October 19, 2015 | K150804 | QBioScan | GZO | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| September 21, 2010 | K101983 | CRITICAL CARE ASSESSMENT | JOM | Substantially Equivalent | Critical Patient Care, Inc. | accessdata.fda.gov |
| February 18, 2009 | K083735 | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | JOM | Substantially Equivalent | Medtechs, LLC | accessdata.fda.gov |
| April 11, 2008 | K080884 | QHRV 1 - HEALTH ASSESSMENT SYSTEM | DPS | Substantially Equivalent | Medtechs, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Galvanic Skin Response Measurement
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Detector And Alarm, Arrhythmia
- All makers of Continuous Measurement Thermometer
Updated January 28, 2023. 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.