Question 1

What types of medical devices does Ortoiberica S.L. manufacture?

Accepted Answer

Ortoiberica S.L. specializes in orthopedic and mobility aids. Their product range includes knee braces with gel suspension systems (like the Aramo T/L Plus and T/XS), supports for the tibia and femur, aluminum walking canes (such as the Ergo Blando), flexible finger splints (Flex.Act), customizable foot orthotics (Antequino AFO), and knee compression sleeves (Sparta V in various sizes). These devices are designed to assist with joint support, mobility, and rehabilitation.

Question 2

Where is Ortoiberica S.L. based, and how does that affect its devices?

Accepted Answer

Ortoiberica S.L. is based in Spain, which means its devices comply with EU medical device regulations. Since these products fall under Class I classification—reserved for low-risk items like orthopedic accessories—they must still meet EUDAMED registration requirements, ensuring traceability and compliance with EU safety standards. The company’s location aligns its manufacturing with EU regulatory frameworks.

Question 3

Which regulatory registries list Ortoiberica S.L.’s devices?

Accepted Answer

Ortoiberica S.L.’s devices are registered in the EUDAMED database, the official European Union portal for medical device information. This registry ensures transparency and compliance tracking for Class I orthopedic and mobility aids under EU regulations. The company’s products are not listed in other major registries because they are low-risk and fall under mandatory EUDAMED reporting.

Question 4

How are Ortoiberica S.L.’s devices classified under EU regulations?

Accepted Answer

Ortoiberica S.L.’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk items like orthopedic supports, mobility aids, and compression sleeves, which pose minimal risk to patients. Class I devices require compliance with basic safety and performance requirements but do not need third-party conformity assessment, though they must still be registered in EUDAMED to demonstrate legal market placement.

Device	Model / Reference	Registries	Class	Status
Ferula Extension Muñeca M.p Flexion T/P	X-5033-	EUDAMED	Class I	Active
Ferula Extensora Activa T/M	X-5021-003	EUDAMED	Class I	Active
Talonera Espolon Central T/S	X-7410-001	EUDAMED	Class I	Active
Sparta V, Categoria 3, 28cm	P-1930-028	EUDAMED	Class I	Active
Sparta Lp, Categoria 4, 26cm	P-1924-026	EUDAMED	Class I	Active
Collar Hensinger C/Plato De Montaje T/M	X-2650-502	EUDAMED	Class I	Active
Ferula Extensora	X-5020-	EUDAMED	Class I	Active
Milwaukee Articulado T/M	X-8850-002	EUDAMED	Class I	Active
Ferula Extension Muñeca M.p Flexion T/G	X-5033-004	EUDAMED	Class I	Active
Sparta V, Categoria 4, 27cm	P-1914-027	EUDAMED	Class I	Active
Baston Amarillo Ergo Blando Aluminio	K-11517-015	EUDAMED	Class I	Active
Connection Emp Cosmetica 27l	P1900-987L	EUDAMED	Class I	Active
Antequino Taeme Dcho T/P	X-8116-011	EUDAMED	Class I	Active
Ferula Extensora Con Resistencia	X-5018-000	EUDAMED	Class I	Active
Sparta Lp, Categoria 4, 23cm	P-1924-023	EUDAMED	Class I	Active
Cuerpo Lanzadera Aleacion Ligera Hembra	P-0053-500	EUDAMED	Class I	Active
Sparta Lp, Categoria 4, 24cm	P-1924-024	EUDAMED	Class I	Active
Cabestrillo Dos Tiras T/G	X-8473-030	EUDAMED	Class I	Active
Rodillera Suspension Neo-Flex T/4	P-5400-004	EUDAMED	Class I	Active
Connection Emp Cosmetica 28l	P-1900-28L	EUDAMED	Class I	Active
Cosmetica Pie Protesico Cauca	P-1900-020	EUDAMED	Class I	Active
Ferula De Dedo Spring	X-5017-	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 23l	P-1900-123L	EUDAMED	Class I	Active
Lso Rectus Mujer T/S	X-1541-002	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 26r	P-1900-026R	EUDAMED	Class I	Active
Funda Cosmetica Dcha 40 Cm	P-0074-002	EUDAMED	Class I	Active
Cuerpo Para Lanzadera En Aleación Ligera	P-0053-000	EUDAMED	Class I	Active
Collar Hensinger C/Plato De Montaje T/S	X-2650-501	EUDAMED	Class I	Active
Ferula Ext.act.art. Inter.prox.t/Xs	X-5026-001	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 25l	P-1900-25L	EUDAMED	Class I	Active
Ferula Extension Muñeca M.p Flexion T/M	X-5033-003	EUDAMED	Class I	Active
Ferula Extensora Con Resistencia T/M	X-5018-003	EUDAMED	Class I	Active
Funda Cosmetica Izda 40 Cm	P-0074-012	EUDAMED	Class I	Active
Rodillera De Gel Suspension Aramo T/M	P-3500-200	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 24r	P-1900-124R	EUDAMED	Class I	Active
Tlso Rectus Mujer T/Xl	X-1741-005	EUDAMED	Class I	Active
Ferula De Dedo Spring T/M	X-5017-003	EUDAMED	Class I	Active
X-1541-005	X-1541-005	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P26-PLY1-CE	EUDAMED	Class I	Active
Media Femoral T/L -par-	P-0068-105	EUDAMED	Class I	Active
Collar Hensinger S/Plato De Montaje T/Xs	X-2650-000	EUDAMED	Class I	Active
Sparta Lp, Categoria 2, 29cm	P-1922-029	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61365C	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63363A	EUDAMED	Class I	Active
Sparta S, Categoria 3, 25cm	P-1933-025	EUDAMED	Class I	Active

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