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Sign in to claim this brandLina Medical ApS
Denmark·DK-MF-000003706
Last updated September 17, 2026
What Lina Medical ApS makes
Lina Medical ApS manufactures single-use endoscopic electrosurgical handpieces, electrodes, and mechanical-cutting polypectomy snares. Their product portfolio also includes single-use surgical retraction systems and blades, earplugs, middle ear decompressors, and electrical mains power extension cables.
The company is based in Denmark, and its devices are categorized as Class I and Class II medical devices. These products are listed in the EUDAMED database, the FDA 510(k) clearance database, and the FDA UDI database.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
Where is Lina Medical ApS located?
Lina Medical ApS is based in Denmark. This information is provided to clarify the geographical origin of the manufacturer, which is relevant for regulatory oversight and supply chain transparency.
What types of medical devices does Lina Medical ApS manufacture?
The company produces a diverse range of single-use medical equipment, including endoscopic electrosurgical handpieces and electrodes, mechanical-cutting polypectomy snares, surgical retraction systems and blades, earplugs, middle ear decompressors, and electrical mains power extension cables. This list reflects the specific product categories manufactured by the company.
How are the devices from Lina Medical ApS classified?
The devices manufactured by Lina Medical ApS are categorized as Class I and Class II medical devices. This classification is based on the regulatory framework used to determine the level of risk and the corresponding controls required for these specific medical products.
Which regulatory registries list the devices produced by Lina Medical ApS?
Devices from Lina Medical ApS are listed in the EUDAMED database, the FDA 510(k) clearance database, and the FDA UDI database. These registries are used to track medical device information and regulatory status, ensuring that the products are documented according to the requirements of the respective health authorities.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Denmark
- Address
- 5, Formervangen, Glostrup, Denmark
- Website
- www.lina-medical.com
- —
- —
- [email protected]
- Phone
- +48 789 105 422
- PRRC Contact
- Paweł Łukaszewicz
- EUDAMED SRN
- DK-MF-000003706
- FDA FEI Number
- 3027454635
- DUNS Number
- 305088619
Catalogue (106)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lina Xcise Model Mor-1515 | K101458 | FDA 510(k) | Class II | Active |
| LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | K171113 | FDA 510(k) | Class II | Active |
| SafeAir Telescopic Smoke Pencil | K182354 | FDA 510(k) | Class II | Active |
| Lina-Bag, Models Lb-60, Lb-100 | K030422 | FDA 510(k) | Class II | Active |
| SafeAir Smoke Evacuator compact | K182224 | FDA 510(k) | Class II | Active |
| LiNA Versascope Outflow Cannula | GMS 702 | EUDAMED | Class I | Active |
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