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
Cosmetica Pie Protesico, Cauca 29r	P-1900-029R	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 26l	P-1900-026L	EUDAMED	Class I	Active
Connection Emp Cosmetica 24d	P-1900-924R	EUDAMED	Class I	Active
Rodilleras De Gel Aramo	P-3500	EUDAMED	Class I	Active
Ferula Extensora T/Extra-P	X-5020-001	EUDAMED	Class I	Active
Funda Cosmet.c/Cono Sup Dcha 40cm	P-0075-002	EUDAMED	Class I	Active
Sparta V, Categoria 3, 23cm	P-1913-023	EUDAMED	Class I	Active
Cosmetica Plastazote B/K T/S	P-0064-001	EUDAMED	Class I	Active
Ferula Stack Proximal T/4	X-5012-004	EUDAMED	Class I	Active
Funda De Espuma Preformada Dcha 44cm	P-0076-003	EUDAMED	Class I	Active
Lanzaderas	P-00L	EUDAMED	Class I	Active
Baston Gris Ergo Blando Aluminio	K-11510-015	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61461C	EUDAMED	Class I	Active
Sparta V, Categoria 3, 24cm	P-1913-024	EUDAMED	Class I	Active
Sparta V, Categoria 2, 25cm	P-1912-025	EUDAMED	Class I	Active
Sparta V, Categoria 5, 29cm	P-1915-029	EUDAMED	Class I	Active
Sparta Lp, Categoria 3, 23cm	P-1923-023	EUDAMED	Class I	Active
Ferula Extension Muñeca M.p Flexion T/P	X-5033-002	EUDAMED	Class I	Active
Sparta S, Categoria 4, 24cm	P-1934-024	EUDAMED	Class I	Active
Baston Gris Ingles Ergo Aluminio	K-11810-015	EUDAMED	Class I	Active
Sparta S, Categoria 3, 24cm	P-1933-024	EUDAMED	Class I	Active
Sparta V, Categoria 1, 26cm	P-1911-026	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca, 27d	P-1900-027R	EUDAMED	Class I	Active
Funda Cosmet.c/Cono Sup Izq 36cm	P-0075-011	EUDAMED	Class I	Active
Connection Emp Cosmetica 23l	P-1900-923L	EUDAMED	Class I	Active
Rodillera Suspension Neo-Flex T/2, 5	P-5400-025	EUDAMED	Class I	Active
Sparta Lp, Categoria 3, 25cm	P-1923-025	EUDAMED	Class I	Active
Antequino Afo Hombre Dcho	X-8115-001	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61361A	EUDAMED	Class I	Active
Tlso Rectus	X-1740-000	EUDAMED	Class I	Active
Adaptador	P-00	EUDAMED	Class I	Active
Sparta V, Categoria 4, 26cm	P-1914-026	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 23d	P-1900-023R	EUDAMED	Class I	Active
Funda De Espuma Preformada Dcha 40 Cm	P-0076-002	EUDAMED	Class I	Active
Funda Cosmetica Dcha 36 Cm	P-0074-001	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61465A	EUDAMED	Class I	Active
Lso Rectus Hombre T/M	X-1542-003	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63265C	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/5, 5 (2 Unid)	X-5010-055	EUDAMED	Class I	Active
Ferula Stack Proximal T/3	X-5012-003	EUDAMED	Class I	Active
Ferula Stack Proximal T/2	X-5012-002	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 29l	P-1900-129L	EUDAMED	Class I	Active
Connection Emp Para Cosmetica	P-1900-000	EUDAMED	Class I	Active
Rodillera Suspension Neo-Flex T/1, 5	P-5400-015	EUDAMED	Class I	Active
Ferula Extensora Activa T/G	X-5021-004	EUDAMED	Class I	Active
Tlso Rectus Mujer T/L	X-1741-004	EUDAMED	Class I	Active
Sparta V, Categoria 2, 27cm	P-1912-027	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62265C	EUDAMED	Class I	Active
Ferula Stack Proximal T/1	X-5012-001	EUDAMED	Class I	Active
Muleta Base 5 Patas Dcha Negro Aluminio	K-12574	EUDAMED	Class I	Active

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