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
Sock Aramo Ancho-Largo	P-63261C	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61463C	EUDAMED	Class I	Active
Lso Rectus Mujer T/Xs	X-1541-001	EUDAMED	Class I	Active
Sparta Lp, Categoria 2, 24cm	P-1922-024	EUDAMED	Class I	Active
Ortesis Dorsiflex.muñeca C/S Art.met.	X-5032-	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63203A	EUDAMED	Class I	Active
Sparta Lp, Categoria 3, 29cm	P-1923-029	EUDAMED	Class I	Active
Funda Espuma Preform C/Cono Sup Dch 44cm	P-0077-003	EUDAMED	Class I	Active
Connection Emp Cosmetica 29l	P-1900-929L	EUDAMED	Class I	Active
Baston Lila Ergo Blando Aluminio	K-11520-015	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63363C	EUDAMED	Class I	Active
Sparta Lp, Categoria 2, 28cm	P-1922-028	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 23r	P-1900-123R	EUDAMED	Class I	Active
Texton Shirt S/M Xs	X-1450-001	EUDAMED	Class I	Active
Sparta V, Categoria 4, 25cm	P-1914-025	EUDAMED	Class I	Active
Sparta Lp, Categoria 3, 24cm	P-1923-024	EUDAMED	Class I	Active
Sparta Lp, Categoria 5, 27cm	P-1925-027	EUDAMED	Class I	Active
Lanzadera Centurion Rd	P-0053-600	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63201C	EUDAMED	Class I	Active
Cosmetica Plastazote B/K T/L	P-0064-003	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 25d	P-1900-025R	EUDAMED	Class I	Active
Lso Rectus Hombre T/Xl	X-1542-005	EUDAMED	Class I	Active
Collar Hensinger S/Plato De Montaje T/S	X-2650-001	EUDAMED	Class I	Active
Ferula Stack Distal	X-5012-	EUDAMED	Class I	Active
Ferula Extensora Con Resistencia T/Xs	X-5018-001	EUDAMED	Class I	Active
Ferula Flex.act.art.inter.prox T/L	X-5025-004	EUDAMED	Class I	Active
Milwaukee Articulado T/S	X-8850-001	EUDAMED	Class I	Active
Sock Aramo Ancho-Largo	P-63365A	EUDAMED	Class I	Active
Connection Emp Cosmetica 26r	P-1900-926R	EUDAMED	Class I	Active
Sparta Lp, Categoria 4, 27cm	P-1924-027	EUDAMED	Class I	Active
Sparta S, Categoria 1, 24cm	P-1931-024	EUDAMED	Class I	Active
Connection Emp Cosmetica 25r	P-1900-925R	EUDAMED	Class I	Active
Soporte Dorsal Rectus Mujer T/L	X-1341-003	EUDAMED	Class I	Active
Antequino Taeme Izdo T/M	X-8116-002	EUDAMED	Class I	Active
Funda Espuma Preform.c/Cono Sup Dch 36cm	P-0077-001	EUDAMED	Class I	Active
Baston Tur/A Ergo Niño/A	K-10006-004	EUDAMED	Class I	Active
Rodillera De Gel Suspension Aramo T/M Plus	P-3500-300	EUDAMED	Class I	Active
Rodillera Suspension Neo-Flex T/5	P-5400-005	EUDAMED	Class I	Active
Ferula Ext.act.art.inter.prox T/Xl	X-5026-005	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62203C	EUDAMED	Class I	Active
Milwaukee Articulado T/L	X-8850-003	EUDAMED	Class I	Active
Baston Ingles Ergo Aluminio	K-1180-015	EUDAMED	Class I	Active
Sparta Lp	SPARTA LP	EUDAMED	Class I	Active
Tlso Rectus Hombre T/S	X-1742-002	EUDAMED	Class I	Active
Baston Ergo Niño/A	K-10006-000	EUDAMED	Class I	Active
Soporte Dorsal Rectus Hombre T/M	X-1342-002	EUDAMED	Class I	Active
Ortesis Dorsiflex.muñeca C/S Art.met.t/S	X-5032-002	EUDAMED	Class I	Active
Media Tibial T/M -par-	P-0068-002	EUDAMED	Class I	Active
Ferula Extensora Activa T/P	X-5021-002	EUDAMED	Class I	Active
Sparta Lp. Categoria 2, 26cm	P-1922-026	EUDAMED	Class I	Active

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