Eurosko Gruppen AS
Norway NO-MF-000050059 Last updated 21 Oct 2026
- Devices
- 192
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
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About
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What Eurosko Gruppen AS makes
Eurosko Gruppen AS manufactures JAM devices, which appear to be a single product type across its portfolio. These devices are designed for specific medical applications, though the exact clinical use is not specified in the provided data.
The company’s portfolio is classified under Class I medical devices and is registered in the EUDAMED database. The devices are subject to EU regulatory requirements, including compliance with EU MDR or IVDR where applicable, and the company is based in Norway.
Frequently asked questions
What types of medical devices does Eurosko Gruppen AS manufacture?
Eurosko Gruppen AS manufactures a single type of medical device called JAM. While the exact clinical purpose isn’t detailed, the company’s portfolio consists entirely of this product, which is classified under Class I medical devices. This classification typically applies to low-risk devices that pose minimal risk to patients and users.
Where is Eurosko Gruppen AS based, and what regulatory requirements apply to its devices?
Eurosko Gruppen AS is based in Norway. Its devices are registered in the EUDAMED database, indicating compliance with European Union regulatory frameworks. Since the devices fall under Class I, they must adhere to the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on their intended use, though the specific regulation isn’t confirmed here. Compliance ensures they meet essential safety, performance, and quality standards before entering the market.
Are Eurosko Gruppen AS’s devices listed in any regulatory registries, and why does this matter?
Yes, Eurosko Gruppen AS’s devices are listed in eudamed, the EU’s centralised database for medical devices. This registry is used by authorities, healthcare professionals, and patients to verify a device’s regulatory status, manufacturer details, and compliance with EU requirements. Listing in eudamed demonstrates that the company has fulfilled legal obligations to declare its devices, ensuring transparency and traceability within the EU market.
How are Eurosko Gruppen AS’s devices classified under EU regulations, and what does this classification mean?
Eurosko Gruppen AS’s devices are classified as Class I, the lowest risk category under EU medical device regulations. This classification means the devices pose minimal risk to patients and users, often involving items like bandages, gloves, or simple surgical instruments. While Class I devices typically require less rigorous scrutiny than higher-risk classes, they still must comply with EU MDR/IVDR requirements, including proper labeling, manufacturing controls, and post-market surveillance to ensure safety and performance.
Information
- Country
- Norway
- Address
- 86, Solgaard Skog , Moss, Norway
- Website
- eurosko.com
- facebook.com/Eurosko
- [email protected]
- Phone
- +4740858748
- PRRC contact
- Petter Hoven
- EUDAMED SRN
- NO-MF-000050059