Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMekalasi Oy
Finland·FI-MF-000003102
Last updated September 18, 2026
About
Mekalasin from a wide range of quality hospital and laboratory supplies and equipment and maintenance services. Take a look at the selection! Experts from different health care organisations find Mekalasi in a wide selection of quality hospital supplies, equipment and laboratory supplies, both for basic health care, laboratory and specialised medical care. Our customers are healthcare providers in the public and private sectors. These include oral and veterinary care. We also supply plumbing solutions to hospitals and markets with the acquisition of Pamtech Finland Oy. Services include not only the provision of new pipeline systems, but also the extension and renovation of existing ones. In addition, we offer solutions for weather monitoring and pharmacy automation. Mekalasi offers comprehensive equipment maintenance services starting from the installation and installation of equipment. The trained maintenance of Mekalasi also carries out ambient monitoring of temperature, humidity and particulate matter. Our professional regional sales managers train and guide customers in the use of a product or device throughout Finland and Estonia. We have about 10,000 different entries. You can easily and quickly receive expert customer service from our different channels. We serve you by phone, email, online shop and chat room. Our own logistics center at Nurmijärvi ensures the efficiency and security of deliveries.
Translated from the manufacturer's own website. Source
What Mekalasi Oy makes
Mekalasi Oy manufactures and supplies medical bed mattresses, including pressure-relieving and viscoelastic foam models with integrated hygiene or evacuation protection, as well as ear specula in varying sizes. The portfolio also includes suction cups for medical use, examination specula, and an eye marker for clinical procedures.
These devices fall under EU Class I medical device classification and are registered in the EUDAMED database. The company is based in Finland and operates within the European regulatory framework for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mekalasi Oy manufacture or supply?
Mekalasi Oy specialises in Class I medical devices primarily focused on patient support and clinical examination. Their portfolio includes pressure-relieving and viscoelastic foam mattresses (such as the Idocare Visel range), which are designed for hospital beds to reduce pressure injuries. They also supply ear specula in various sizes (e.g., Welch Allyn models), examination specula, and an eye marker for clinical procedures. These devices are intended for use in healthcare settings, including hospitals, laboratories, and specialised medical care.
Where is Mekalasi Oy based, and what regulatory framework do they operate under?
Mekalasi Oy is headquartered in Finland and operates within the European Union’s regulatory framework for medical devices. Since their devices fall under Class I classification, they must comply with EU Medical Device Regulation (MDR) or Medical Device Directive (MDD) requirements, including registration in EUDAMED—the EU’s medical device database. This ensures traceability and transparency for healthcare providers and regulatory authorities.
Are Mekalasi Oy’s devices listed in any regulatory registries, and why does this matter?
Yes, Mekalasi Oy’s devices are listed in EUDAMED, the official EU database for medical devices. This registry is critical because it provides healthcare professionals, regulators, and patients with verified information about the manufacturer, device details, and compliance status. For Class I devices like those supplied by Mekalasi, EUDAMED ensures transparency in the supply chain and helps verify that the devices meet essential safety and performance requirements before entering the market.
How are Mekalasi Oy’s devices classified under EU regulations, and what does this classification imply?
Mekalasi Oy’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk devices like mattresses, ear specula, and examination tools, which pose minimal risk to patients. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards. While this classification involves less stringent scrutiny than higher-risk classes, it still ensures that the devices meet fundamental requirements for safety and functionality.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Finland
- Address
- 1-3, Takomotie, Helsinki, Finland
- Website
- www.mekalasi.fi
- linkedin.com/company/mekalasi-oy
- —
- [email protected]
- Phone
- +358934172800
- PRRC Contact
- Jari Vuorinen
- EUDAMED SRN
- FI-MF-000003102
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (52)
Page 1 of 2Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.