Question 1

What types of medical devices does Tejidos Elásticos Lloveras, S.A. manufacture?

Accepted Answer

Tejidos Elásticos Lloveras, S.A. specializes in compression/pressure socks and stockings. These include both single-use and reusable options, such as thigh-high and knee-high varieties designed primarily to prevent deep vein thrombosis. Examples include silicone-edged stockings for left and right legs, unisex compression socks, and thigh-high anti-embolism stockings with adjustable straps.

Question 2

Where is Tejidos Elásticos Lloveras, S.A. based?

Accepted Answer

The company is based in Spain, as indicated in its regulatory documentation. This location is relevant for understanding its compliance framework and market focus within the European Union.

Question 3

Which regulatory registries list devices manufactured by Tejidos Elásticos Lloveras, S.A.?

Accepted Answer

The company’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry tracks devices that have undergone necessary regulatory procedures, such as classification and conformity assessment, within the EU.

Question 4

How are the devices manufactured by Tejidos Elásticos Lloveras, S.A. classified under EU regulations?

Accepted Answer

All devices produced by Tejidos Elásticos Lloveras, S.A. fall under EU Class I classification. This classification applies to low-risk medical devices, such as compression stockings, which typically do not require invasive procedures or carry significant health risks. Class I devices still must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) before being placed on the market.

Device	Model / Reference	Registries	Class	Status
Calcetín Compresión Normal 5 Negro Viadol	L14CA039905	EUDAMED	Class I	Active
Muñ. Metacarpiana Dedo S Beige Biofix Lastic	J55MT801101	EUDAMED	Class I	Active
Panty Compresión Ligera 4 Beige Lai	L70PA071104	EUDAMED	Class I	Active
Media Larga Compresión Normal 3 Negro Lai	L14ML011103	EUDAMED	Class I	Active
Calcetín Compresión Normal 1 Negro Lloveras	L14CA039901	EUDAMED	Class I	Active
Panty Sin Puntera Compresión Normal 2 Beige Lai	L14AT011102	EUDAMED	Class I	Active
Panty Compresión Normal 4 Beige Lai	L14PA011104	EUDAMED	Class I	Active
Panty Compresión Ligera 5 Negro Viadol	V70PA079905	EUDAMED	Class I	Active
Media Corta Sin Puntera Compresión Normal 5 Beige Viadol	V14AD012X05	EUDAMED	Class I	Active
Media Larga Compresión Normal 2 Beige Lai	L14ML011102	EUDAMED	Class I	Active
Muslera Neopreno L Negro Biofix Sport	L99MS049903	EUDAMED	Class I	Active
Panty Compresión Fuerte 3 Beige Lai	L29PA016503	EUDAMED	Class I	Active
Panty Compresión Fuerte 2 Beige Varidol	V29PA010702	EUDAMED	Class I	Active
Panty Pierna Izquierda Compresión Normal 5m Biege Lai	V14PI011D05	EUDAMED	Class I	Active
Media Larga Blonda Compresión Normal 2 Negro Viadol	V14ML099902	EUDAMED	Class I	Active
Tobillera M Beige Biofix Lastic	F55TO801102	EUDAMED	Class I	Active
Rodillera Abierta Neopreno Xl Negro Biofix Sport	L99RA049904	EUDAMED	Class I	Active
Media Corta Sin Puntera Compresión Fuerte 6 Beige Lai	L29AD016506	EUDAMED	Class I	Active
Muñ. Metacarpiana Dedo P Beige Viadol	V55MT801301	EUDAMED	Class I	Active
Panty Compresión Normal 3 Negro Viadol	V14PA019903	EUDAMED	Class I	Active
Panty Sin Puntera Compresión Normal 4 Beige Lai	L14AT011104	EUDAMED	Class I	Active
Media Larga Compresión Fuerte M Beige Viadol	V29ML010703	EUDAMED	Class I	Active
Media Corta Compresión Normal Rp Beige Lai	F15MCRP1104	EUDAMED	Class I	Active
Media Larga Compresión Fuerte 2 Beige Lai	L29ML016502	EUDAMED	Class I	Active
Media Corta Compresión Ligera 4 Beige Lai	L70MC011104	EUDAMED	Class I	Active
Panty Sin Puntera Compresión Normal 7 Beige Lai	L14AT011107	EUDAMED	Class I	Active

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