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 Estrecho-Largo	P-61461	EUDAMED	Class I	Active
Sparta Lp, Categoria 4, 25cm	P-1924-025	EUDAMED	Class I	Active
Ferula Extensora T/M	X-5020-003	EUDAMED	Class I	Active
Connection Emp Cosmetica 27r	P-1900-927R	EUDAMED	Class I	Active
Sparta V, Categoria 4, 28cm	P-1914-028	EUDAMED	Class I	Active
Baston Infantil Ergo Amarillo/Negro	K-10006-003	EUDAMED	Class I	Active
Antequino Afo	X-8115-	EUDAMED	Class I	Active
Rodillera De Gel Suspension Aramo T/L	P-3500-400	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown	P-1900-120	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 26l	P-1900-126L	EUDAMED	Class I	Active
Talonera Espolón Desplazado T/L	X-7412-003	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 27l	P-1900-027L	EUDAMED	Class I	Active
Ferula Flex.act.art.inter.prox.t/Xl	X-5025-005	EUDAMED	Class I	Active
Ferula Flex.act.art.inter.prox. T/S	X-5025-002	EUDAMED	Class I	Active
Collar Hensinger C/Plato De Montaje T/L	X-2650-503	EUDAMED	Class I	Active
Talonera Espolón Central T/M	X-7410-002	EUDAMED	Class I	Active
Aria Válvula	P-9014-400	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61465C	EUDAMED	Class I	Active
Ferula Ext.act.art.inter.prox.t/M	X-5026-003	EUDAMED	Class I	Active
Sparta V, Categoria 2, 24cm	P-1912-024	EUDAMED	Class I	Active
Ferula Ext.act.art.inter.prox T/S	X-5026-002	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/1 (2 Unid)	X-5010-001	EUDAMED	Class I	Active
Sparta V, Categoria 1, 26cm	P-1911-025	EUDAMED	Class I	Active
Baston Articulado Negro	K-11714-015	EUDAMED	Class I	Active
Ferula Extensora De Dedos T/L	X-5016-004	EUDAMED	Class I	Active
Sparta S, Categoria 3, 27 Cm	P-1933-027	EUDAMED	Class I	Active
Sparta S, Categoria 1, 26cm	P-1931-026	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 24l	P-1900-124L	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62463A	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63463C	EUDAMED	Class I	Active
Funda Cosmet.c/Cono Sup Izq 40cm	P-0075-012	EUDAMED	Class I	Active
Media Femoral T/S-M -par-	P-0068-102	EUDAMED	Class I	Active
Ferula Extensora De Dedos T/Xs	X-5016-001	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 28r	P-1900-128R	EUDAMED	Class I	Active
Talonera Espolón Central T/L	X-7410-003	EUDAMED	Class I	Active
Faja Rectus	X-1240	EUDAMED	Class I	Active
Ferula De Dedo Spring T/Xl	X-5017-005	EUDAMED	Class I	Active
Sparta V, Categoria 2, 29cm	P-1912-029	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62263C	EUDAMED	Class I	Active
Sparta S, Categoria 2, 26cm	P-1932-026	EUDAMED	Class I	Active
Sparta S, Categoria 4, 26cm	P-1934-026	EUDAMED	Class I	Active
Soporte Dorsal Rectus Mujer T/S	X-1341-001	EUDAMED	Class I	Active
Aria	P-9014-	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61265A	EUDAMED	Class I	Active
Ferula Extensora Con Resistencia T/Xl	X-5018-005	EUDAMED	Class I	Active
Rodillera Suspensión Neo-Flex	P-5400-	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63263C	EUDAMED	Class I	Active
Cabestrillo Dos Tiras T/E-G	X-8473-040	EUDAMED	Class I	Active
Talonera Espolón Desplazado T/S	X-7412-001	EUDAMED	Class I	Active
Funda De Espuma Preformada Izq. 36 Cm	P-0076-011	EUDAMED	Class I	Active

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