Brainscan Spółka Akcyjna
Active in EUDAMEDPolandfrom SRN EUDAMED SRN PL-MF-000022152
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 2 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What Brainscan Spółka Akcyjna makes
BrainScan Spółka Akcyjna manufactures computed tomography (CT) systems designed for brain imaging, including automated diagnostic support tools for identifying brain pathologies. These devices are intended to assist in the detection and evaluation of neurological conditions through advanced imaging technology.
The company’s CT systems fall under Class IIa classification in the EU regulatory framework and are registered in the EUDAQMED database. BrainScan Spółka Akcyjna is headquartered in Poland.
Catalogue
BrainScan CT Ref BrainScan CT 1.3
CE MDR EUDAMED
Company details
- EUDAMED SRN
- PL-MF-000022152
- EU VAT number
- 5862321880
- EUDAMED status
- Active
- EUDAMED registered name
- BRAINSCAN SPÓŁKA AKCYJNA
- EUDAMED abbreviated name
- BRAINSCAN S.A.
- Registered address
- 10, PROF. ZDZISŁAWA KIETURAKISA, 80-741, GDAŃSK, Poland
- Website
- www.brainscan.ai
- [email protected]
- Phone
- +48 602 453 345
- PRRC contact
- Edyta Wierciak-Bożętka
EUDAMED certificates
2 certificates1 valid, 1 expiredMDR 2next expiry 6 Feb 2029
TUV NORD Polska Sp. z o.o 2274 2 certificates
- TNP/MDR/0046/4823/2026 Reissued
Quality management system EU MDR
- Issued
- 3 Feb 2026
- Expires
- 6 Feb 2029
- Valid from
- 7 Feb 2026
- TNP/MDR/0008/4823/2023 Expired
Quality management system EU MDR
- Issued
- 7 Feb 2023
- Expires
- 6 Feb 2026
Frequently asked questions
How many devices does BRAINSCAN SPÓŁKA AKCYJNA have in the registry?
The registry currently lists 1 device for BRAINSCAN SPÓŁKA AKCYJNA. Devices recorded under merged duplicate company entries are counted once.
Which registries list BRAINSCAN SPÓŁKA AKCYJNA's devices?
Among its 1 most recently registered device, BRAINSCAN SPÓŁKA AKCYJNA has devices listed in EUDAMED (1 device).
What risk classes do BRAINSCAN SPÓŁKA AKCYJNA's devices fall under?
Among its 1 most recently registered device, the classes recorded for BRAINSCAN SPÓŁKA AKCYJNA's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for BRAINSCAN SPÓŁKA AKCYJNA?
EUDAMED lists 2 certificates for BRAINSCAN SPÓŁKA AKCYJNA (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-02-03.
What are the newest devices from BRAINSCAN SPÓŁKA AKCYJNA in the registry?
The most recently registered devices listed for BRAINSCAN SPÓŁKA AKCYJNA include BrainScan CT.