Manufacturer

Linamed

SwitzerlandLegal entities : LiNA Medical AG

Markets : Denmark · Germany · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 16 · class I, II · latest in 2024 · see on the FDA website

EU representative : LiNA Medical Polska Sp. z o.o. (Poland)

7 categories, 12 models including 12 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Various instruments for general and multidisciplinary surgery - other	Z12019099	LiNA SeaStar 4000-R-SL, 4000-R-SS, 4000-R-VL, 4000-R-VS, 4000-R-VV;3 refs LiNA SeaStar 4000-S-Q, 4000-S-SL, 4000-S-SS, 4000-S-VL, 4000-S-VS, 4000-S-VV3 refs LiNA Skin Hook3 refs LiNA SkinHook SH-110-NS; SH-220-NS2 refs	I, IIa MDR	EUDAMED record Report an error
Genitourinary endoscopy instruments - other	Z12020799	LiNA OperaScope Recording Module OP-RM-1-UK LiNA Versascope Sheath GMS805; GMS815-E2 refs	I MDR	EUDAMED record Report an error
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - other	Z12020499	LiNA OperaScope Recording Module OP-RM-1-AUS LiNA OperaScope Recording Module OP-RM-1-EU	I MDR	EUDAMED record Report an error
Capillary blood collection devices - accessories	W0501010280	BRENNER MEDICAL Blood Sampler Blood Sampler 4301, 4301-BR2 refs	IIa MDR	EUDAMED record Report an error
Endometrial ablation equipment	Z12080201	LiNA Librata 2.0 LIB2-1	IIb MDR	EUDAMED record Report an error
Genitourinary endoscopy instruments - consumables	Z12020785	LiNA OperaScope Tubing & Drape kit OP-TDK-6-I	IIa MDR	EUDAMED record Report an error
Morcellators	Z12080204	LiNA Xcise MOR-1515-1-I, MOR-1515-6-I, MOR2-1515-6-I3 refs	IIb MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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