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Lina 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
LinkedIn: —
Facebook: —
Email: [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)

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Device	Model / Reference	Registries	Class	Status
LiNA CystoVu™ HD Grasper	CYV-GRA-5	FDA UDI	Class II	Active
LiNA Bipolar Loop™	BL-160	FDA UDI	Class II	Active
LiNA OperaScope Angled Lasso	OP-LAS10A-3	FDA UDI	Class I	Active
LiNA OperaScope™ Rat Tooth Alligator Grasper	OP-GRA-6	FDA UDI	Class I	Active
Meniett™ Earplug, Blue, 16 mm	MT-EP-16	FDA UDI	Class II	Active
LiNA OperaScope™ with HDMI cable	OP-200-6	FDA UDI	Class II	Active
LiNA Xcise™, Laparoscopic Morcellator	MOR-1515-6	FDA UDI	Class II	Active
LiNA OperåScope™ Needle 8mm	OP-NEE8-6	FDA UDI	Class II	Active
LiNA Skin Hook™	SH-130	FDA UDI	Class I	Active
LiNA OperaScope™ with HDMI cable	OP-200-6	FDA UDI	Class II	Unknown
Meniett™ Earplug, Green, 14 mm	MT-EP-14	FDA UDI	Class II	Active
LiNA PowerBlade™	5010-E	FDA UDI	Class II	Active
LiNA Xcise™, Laparoscopic Morcellator	MOR-1515-1	FDA UDI	Class II	Unknown
LiNA OperaScope™ Biopsy Forceps	OP-FCP-6	FDA UDI	Class I	Unknown
LiNA OperåScope™ Needle 4mm	OP-NEE4-6	FDA UDI	Class II	Active
Meniett ® Pulse Generator- LOANER	MT-GEN-LO	FDA UDI	Class II	Active
LiNA OperaScopeTM Lasso	OP-LAS16-3	FDA UDI	Class I	Active
LiNA PowerBlade™	5010	FDA UDI	Class II	Active
Meniett™ Power Cord, United Kingdom and Ireland	MT-CAB-UK	FDA UDI	Class II	Active
LiNA PowerBlade™	5005-E-C-160	FDA UDI	Class II	Active
LiNA SeaStar™	4000-S-SS	FDA UDI	Class I	Active
Meniett™ Earplug, Grey, 11 mm	MT-EP-11	FDA UDI	Class II	Active
LiNA PowerBlade™	5005-420	FDA UDI	Class II	Unknown
LiNA SeaStar™	4000-S-VS	FDA UDI	Class I	Active
LiNA OperåScope™ Recording Module	OP-RM-1	FDA UDI	Class II	Unknown
LiNA OperaScope™ with HDMI cable	OP-200-6	FDA UDI	Class II	Unknown
LiNA OperåScope™ with HDMI cable & LCD	OP-201-6	FDA UDI	Class II	Unknown
LiNA PowerBlade™	5005-C-160	FDA UDI	Class II	Active
LiNA Xcise™, Laparoscopic Morcellator	MOR-1515-1	FDA UDI	Class II	Active
Meniett™ Earplug, Red, 12.5 mm	MT-EP-12-5	FDA UDI	Class II	Active
Meniett™ Earplug, Grey, 18 mm	MT-EP-18	FDA UDI	Class II	Active
LiNA OperaScope™ Tubing & Drape kit	OP-TDK-6	FDA UDI	Class I	Unknown
LiNA OperaScope™ Tubing & Drape kit	OP-TDK-6	FDA UDI	Class I	Active
Meniett™ Earplug, Clear, 19 mm	MT-EP-19	FDA UDI	Class II	Active
Meniett™ Power Cord, North America	MT-CAB-US	FDA UDI	Class II	Active
LiNA OperaScope Angled Lasso	OP-LAS16A-3	FDA UDI	Class I	Active
LiNA PowerBlade Plus™	5C-330-Y	FDA UDI	Class II	Unknown
LiNA Versascope Sheath	GMS 805	EUDAMED	Class I	Active
SafeAir combi (SFR-combi-US)	K223932	FDA 510(k)	Class II	Active
LiNA OperaScope Needle	K221085	FDA 510(k)	Class II	Active
Lina Powerblade, Model 5005, 5005-E, 5005-C, 5005-150, 5000-C-150, 5005-E-C-150, 5005-420, 5005-C-420, 5005-E-420, 5005-E-C-420,	K063025	FDA 510(k)	Class II	Active
Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size	K130305	FDA 510(k)	Class II	Active
LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module	K193007	FDA 510(k)	Class II	Active
Lina Gold Loop Hc	K132135	FDA 510(k)	Class II	Active
LiNA PowerBlade Plus HC	K142757	FDA 510(k)	Class II	Active
LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)	K240227	FDA 510(k)	Class II	Active
LiNA SafeAir Smoke Pencil	K142538	FDA 510(k)	Class II	Active
Lina Loop, Models: El-160-4, El-160-8, El-200-4, El-200-8	K070315	FDA 510(k)	Class II	Active
Lina Powerblade Plus	K132837	FDA 510(k)	Class II	Active
SafeAir Smoke Pencil	K143145	FDA 510(k)	Class II	Active

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