ASPEL Spółka Akcyjna
Active in EUDAMEDPolandfrom SRN EUDAMED SRN PL-MF-000018796
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
CardioTEST Beta System Ref 07-103-0039
Aspel Ecg Amber Ref 07-101-0405
Company details
- EUDAMED SRN
- PL-MF-000018796
- EU VAT number
- PL6771016189
- EUDAMED status
- Active
- EUDAMED registered name
- ASPEL Spółka Akcyjna
- EUDAMED abbreviated name
- ASPEL S.A.
- Registered address
- 33, os. H.Sienkiewicza, 32-080, Zabierzów, Poland
- Website
- aspel.com.pl
- [email protected]
- PRRC contact
- Damian Bryk
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 15 Jan 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1032460-1 Issued
Quality management system EU MDR
- Issued
- 21 Jan 2025
- Expires
- 15 Jan 2030
From the company website
By clicking on the "I confirm" button, I declare that I am a person entitled to read the content on the ASPEL website and therefore am not a layman within the meaning of Article 2(38) of Regulation 2017/745. The website www.ASPEL.com.pl is intended for people who formally have a health/medical education and are entitled as recipients of advertising content on medical devices intended for use by professionals. Other users are asked to leave the website www.ASPEL.com.pl
Frequently asked questions
How many devices does ASPEL Spółka Akcyjna have in the registry?
The registry currently lists 2 devices for ASPEL Spółka Akcyjna. Devices recorded under merged duplicate company entries are counted once.
Which registries list ASPEL Spółka Akcyjna's devices?
Among its 2 most recently registered devices, ASPEL Spółka Akcyjna has devices listed in EUDAMED (2 devices).
What risk classes do ASPEL Spółka Akcyjna's devices fall under?
Among its 2 most recently registered devices, the classes recorded for ASPEL Spółka Akcyjna's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ASPEL Spółka Akcyjna?
EUDAMED lists 1 certificate for ASPEL Spółka Akcyjna (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-01-21.
What are the newest devices from ASPEL Spółka Akcyjna in the registry?
The most recently registered devices listed for ASPEL Spółka Akcyjna include CardioTEST Beta System and ASPEL ECG AMBER.