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
Media Tibial / Femoral	P-0068-	EUDAMED	Class I	Active
Sparta V, Categoria 3, 25cm	P-1913-025	EUDAMED	Class I	Active
Rodillera De Gel Suspension Aramo T/L Plus	P-3500-500	EUDAMED	Class I	Active
Sparta V, Categoria 2, 28cm	P-1912-028	EUDAMED	Class I	Active
Baston Ergo Blando Aluminio	K-11500-015	EUDAMED	Class I	Active
Ferula Flex.act.art.inter.prox.	X-5025-	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63265A	EUDAMED	Class I	Active
Rodillera De Gel Suspension Aramo T/Xs	P-3500-000	EUDAMED	Class I	Active
Milwaukee Con Patilla T/L	X-8808-003	EUDAMED	Class I	Active
Sparta V, Categoria 3, 27cm	P-1913-027	EUDAMED	Class I	Active
Universal Mini Valvula	P-9014-700	EUDAMED	Class I	Active
Antequino Afo Mujer Izdo	X-8115-022	EUDAMED	Class I	Active
Sparta S, Categoria 2, 24 Cm	P-1932-024	EUDAMED	Class I	Active
Sparta V, Categoria 2, 23cm	P-1912-023	EUDAMED	Class I	Active
Tlso Rectus Hombre T/Xs	X-1742-001	EUDAMED	Class I	Active
Media Tibial T/S -par-	P-0068-001	EUDAMED	Class I	Active
Sparta Lp, Categoria 2, 27cm	P-1922-027	EUDAMED	Class I	Active
Muleta Artritica	K-12550	EUDAMED	Class I	Active
Media Tibial T/Gl-Par-	P-0068-003	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 29l	P-1900-029L	EUDAMED	Class I	Active
Ferula Extensora De Dedos T/Xl	X-5016-005	EUDAMED	Class I	Active
Sparta Lp, Categoria1, 26cm	P-1921-026	EUDAMED	Class I	Active
Funda De Espuma Preformada Izq. 40 Cm	P-0076-012	EUDAMED	Class I	Active
Sparta S, Categoria 2, 25cm	P-1932-025	EUDAMED	Class I	Active
Funda Cosmetica Dcha 44 Cm	P-0074-003	EUDAMED	Class I	Active
Ferula Extensora Activa T/Extra-G	X-5021-005	EUDAMED	Class I	Active
Tlso Rectus Mujer T/M	X-1741-003	EUDAMED	Class I	Active
Connection Emp Cosmetica 25l	P-1900-925L	EUDAMED	Class I	Active
Antequino Taeme Izdo T/G	X-8116-003	EUDAMED	Class I	Active
Funda Espuma Preform C/Cono Sup Dch 40cm	P-0077-002	EUDAMED	Class I	Active
Sparta V, Categoria 2, 26cm	P-1912-026	EUDAMED	Class I	Active
Lso Rectus Hombre T/S	X-1542-002	EUDAMED	Class I	Active
Texton Shirt S/M Xg	X-1450-005	EUDAMED	Class I	Active
Funda Cosmet.c/Cono Sup Izq 44cm	P-0075-013	EUDAMED	Class I	Active
Plato Valvula Aria	P-9014-600	EUDAMED	Class I	Active
Milwaukee Completo T/L	X-8800-003	EUDAMED	Class I	Active
Milwaukee Completo T/M	X-8800-002	EUDAMED	Class I	Active
Baston Turquesa Ergo Blando Aluminio	K-11513-015	EUDAMED	Class I	Active
Funda Espuma Preform C/Cono Sup Izq 40cm	P-0077-012	EUDAMED	Class I	Active
Cabestrillo Dos Tiras T/P	X-8473-010	EUDAMED	Class I	Active
Talonera Espolón	X-7400-000	EUDAMED	Class I	Active
Sparta S, Categoria 1, 25cm	P-1931-025	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 28r	P-1900-028R	EUDAMED	Class I	Active
Funda De Espuma Preformada Dcha 36 Cm	P-0076-001	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62365C	EUDAMED	Class I	Active
Lanzadera Egilona 0059 Verde	P-0059-500	EUDAMED	Class I	Active
Antequino Taeme Izdo T/Extra-G	X-8116-004	EUDAMED	Class I	Active
Sparta Lp, Categoria 4, 29cm	P-1924-029	EUDAMED	Class I	Active
Sparta Lp, Categoria 5, 29cm	P-1925-029	EUDAMED	Class I	Active
Sparta V, Categoria 5, 26cm	P-1915-026	EUDAMED	Class I	Active

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