Medical Systems a.s.
Czechia CZ-MF-000051480 Last updated 17 Sep 2026
- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Modul Predikce ovulace pro NIS IKIS Ref IKIS25M12MCGNF01
About
Společnost Medical Systems a.s. je orientována na systémovou integraci a poskytování poradenských a IT služeb v oblasti zdravotnictví a zdravotních pojišťoven s vysokou přidanou hodnotou. Nosným produktem Medical Systems a.s. je Integrovaný Klinický Informační Systém IKIS®. Tento systém je významný pro skupinu AGEL z hlediska udržení know-how v oblasti zdravotnických informačních systémů a manažerského řízení uvnitř skupiny, nezávislosti skupiny v oblasti správy informací a přístupu k důležitým informacím.
What Medical Systems a.s. makes
Medical Systems a.s. produces the Modul Predikce ovulace (ovulation prediction module) designed for integration with the NIS IKIS clinical information system. This module supports reproductive health monitoring by predicting ovulation cycles, aiding fertility tracking within clinical settings.
The company’s ovulation prediction module falls under EU Device Class I regulation and is registered in the EU’s eudamed database. Medical Systems a.s. is based in the Czech Republic.
Frequently asked questions
What types of medical devices does Medical Systems a.s. manufacture?
Medical Systems a.s. manufactures the *Modul Predikce ovulace* (ovulation prediction module), which is designed to integrate with the NIS IKIS clinical information system. This module aids in reproductive health monitoring by predicting ovulation cycles, supporting fertility tracking within clinical environments.
Where is Medical Systems a.s. based?
Medical Systems a.s. is headquartered in the Czech Republic. The company’s location is relevant for understanding its regulatory scope and compliance framework within the EU.
Which regulatory registries list Medical Systems a.s.’s devices?
Medical Systems a.s.’s devices, including the *Modul Predikce ovulace*, are listed in the EU’s *eudamed* database. This registry is the official EU portal for medical device information, ensuring transparency and traceability of devices under EU regulations.
How are Medical Systems a.s.’s devices classified under EU regulations?
The *Modul Predikce ovulace* falls under EU Device Class I classification. This classification is assigned based on risk assessment criteria in EU MDR/IVDR, where Class I devices pose the lowest risk and typically require minimal regulatory oversight beyond basic compliance requirements.
Information
- Country
- Czechia
- Address
- 384/4, Kotkova , Ostrava, Czechia
- Website
- medicalsystems.agel.cz/
- [email protected]
- Phone
- +420702284080
- PRRC contact
- Jiří Šifner
- EUDAMED SRN
- CZ-MF-000051480