MLase GmbH
Germany DE-MF-000015881 Last updated 21 Oct 2026
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- Devices
- 2
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
ELIOS laser console Ref 513185
ELIOS laser console Ref 512293
EUDAMED certificates
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2551152-1 Issued
Quality management system EU MDR
- Issued
- 6 Feb 2025
- Expires
- 5 Feb 2030
Related companies
Notified bodies
About
Excimer laser solutions for OEM and industrial systems. High precision, long-term stability, and seamless integration into complex systems.
What MLase GmbH makes
MLase GmbH manufactures excimer laser consoles, including the ELIOS system, designed for precision applications in industrial and OEM environments. These devices are engineered for high accuracy and long-term operational stability, supporting integration into complex manufacturing or processing systems.
The company’s excimer laser consoles fall under EU Device Class IIb classification and are registered in the EU’s eudamed database. The manufacturer is based in Germany.
Frequently asked questions
What types of medical devices does MLase GmbH manufacture?
MLase GmbH specializes in excimer laser consoles, such as the ELIOS system. These devices are developed for industrial and OEM applications, emphasizing high precision, long-term stability, and seamless integration into complex systems. Their focus is on enabling accurate laser-based processes in manufacturing or processing environments.
Where is MLase GmbH based?
MLase GmbH is headquartered in Germany. The company’s location in Germany aligns with its focus on precision engineering and regulatory compliance within the European market.
Which regulatory registries list MLase GmbH’s devices?
MLase GmbH’s excimer laser consoles, including the ELIOS system, are registered in the EU’s eudamed database. This platform is the official EU registry for medical devices, ensuring transparency and traceability of authorized products under EU regulations.
How are MLase GmbH’s devices classified under EU regulations?
MLase GmbH’s excimer laser consoles, such as the ELIOS system, fall under EU Device Class IIb. This classification is determined by factors like the device’s intended use, potential risks, and the level of intervention it involves. Class IIb devices require additional scrutiny to ensure safety and performance, including conformity assessment procedures before authorization.
Information
- Country
- Germany
- Address
- 17, Industriestrasse, Germering, Germany
- Website
- www.mlase.com
- linkedin.com/company/mlase-gmbh
- [email protected]
- Phone
- +498989418500
- PRRC contact
- Anika Reibenspiess
- EUDAMED SRN
- DE-MF-000015881