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
Soporte Dorsal Rectus Mujer T/M	X-1341-002	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62203A	EUDAMED	Class I	Active
Ferula Stack Proximal T/6	X-5012-006	EUDAMED	Class I	Active
Antequino Taeme Dcho T/M	X-8116-012	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62363A	EUDAMED	Class I	Active
Sparta Lp, Categoria 3, 26cm	P-1923-026	EUDAMED	Class I	Active
Cosmetica Tibial Redonda	P-0062-000	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/6 (2 Unid)	X-5010-006	EUDAMED	Class I	Active
Plataforma Laminacion Pediátrica	P-0027-900	EUDAMED	Class I	Active
Tlso Rectus Mujer T/Xxl	X-1741-006	EUDAMED	Class I	Active
Collar Hensinger	X-2650-	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 28l	P-1900-128L	EUDAMED	Class I	Active
Talonera Espolón Desplazado T/M	X-7412-002	EUDAMED	Class I	Active
Milwaukee Con Patilla T/S	X-8808-001	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/7 (2 Unid)	X-5010-007	EUDAMED	Class I	Active
Ferula Flex.act.art.inter.prox.t/M	X-5025-003	EUDAMED	Class I	Active
Sparta S, Categoria 5, 28cm	P-1935-028	EUDAMED	Class I	Active
Sparta S	P-1930-000	EUDAMED	Class I	Active
Ferula Extensora T/P	X-5020-002	EUDAMED	Class I	Active
Sparta Lp, Categoria 5, 26cm	P-1925-026	EUDAMED	Class I	Active
Rodillera Suspension Neo-Flex T/3	P-5400-003	EUDAMED	Class I	Active
Rodillera De Gel Suspension Aramo T/S	P-3500-100	EUDAMED	Class I	Active
Lso Rectus Hombre T/Xs	X-1542-001	EUDAMED	Class I	Active
Antequino Taeme Dcho T/G	X-8116-013	EUDAMED	Class I	Active
Tlso Rectus Hombre T/L	X-1742-004	EUDAMED	Class I	Active
Antequino Taeme Dcho T/Extra-G	X-8116-014	EUDAMED	Class I	Active
Soporte Lumbar Rectus Hombre T/S	X-1242-001	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63261A	EUDAMED	Class I	Active
Ferula Stack Proximal T/5	X-5012-005	EUDAMED	Class I	Active
Media Femoral T/M -par-	P-0068-103	EUDAMED	Class I	Active
Texton Shirt S/M G	X-1450-004	EUDAMED	Class I	Active
Sparta V, Categoria 4, 24cm	P-1914-024	EUDAMED	Class I	Active
Sparta S, Categoria 5, 27cm	P-1935-027	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/2 (2 Unid)	X-5010-002	EUDAMED	Class I	Active
Muleta Base 5 Patas Izq Negro Aluminio	K-12575	EUDAMED	Class I	Active
Texton Shirt Xs	X-1400-001	EUDAMED	Class I	Active
Sparta V, Categoria 4, 23cm	P-1914-023	EUDAMED	Class I	Active
Cabestrillo Dos Tiras T/M	X-8473-020	EUDAMED	Class I	Active
Connection Emp Para Cosmetica 28d	P-1900-28R	EUDAMED	Class I	Active
Sparta V, Categoria 3, 26cm	P-1913-026	EUDAMED	Class I	Active
Texton Shirt	X-1400-002	EUDAMED	Class I	Active
Sparta Lp, Categoria 1, 25 Cm	P-1921-025	EUDAMED	Class I	Active
Sparta S, Categoria 2, 28cm	P-1932-025	EUDAMED	Class I	Active
Baston Granate Ergo Blando Aluminio	K-11516-015	EUDAMED	Class I	Active
Funda Cosmet.c/Cono Sup Dcha 36cm	P-0075-001	EUDAMED	Class I	Active
Lanzadera 0060	P-0060-000	EUDAMED	Class I	Active
Media Femoral T/S -par-	P-0068-101	EUDAMED	Class I	Active
Rodillera Suspension Neo-Flex T/2	P-5400-002	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/3 (2 Unid)	X-5010-003	EUDAMED	Class I	Active
Tlso Rectus Mujer T/S	X-1741-002	EUDAMED	Class I	Active

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