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
Ferula Extensora /extra-G	X-5020-005	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62201C	EUDAMED	Class I	Active
Sparta V, Categoria 5, 27cm	P-1915-027	EUDAMED	Class I	Active
Milwaukee Completo T/S	X-8800-001	EUDAMED	Class I	Active
Sparta, Categoria 3, 28cm	P-1933-028	EUDAMED	Class I	Active
Ferula Extensora Activa T/Extra-P	X-5021-001	EUDAMED	Class I	Active
Tlso Rectus Mujer T/Xs	X-1741-001	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 25l	P-1900-025L	EUDAMED	Class I	Active
Milwaukee Con Patilla T/M	X-8808-002	EUDAMED	Class I	Active
Soporte Dorsal Rectus Hombre T/L	X-1342-003	EUDAMED	Class I	Active
Antequino Afo Hombre Izdo	X-8115-002	EUDAMED	Class I	Active
Tlso Rectus Hombre T/M	X-1742-003	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 29r	P-1900-129R	EUDAMED	Class I	Active
Baston Negro Ingles Ergo Aluminio	K-11864-015	EUDAMED	Class I	Active
Lso Rectus Mujer T/Xxl	X-1542-006	EUDAMED	Class I	Active
Sparta S, Categoria 4, 28cm	P-1934-028	EUDAMED	Class I	Active
Funda De Espuma Preformada Izq. 44 Cm	P-0076-013	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/4 (2 Unid)	X-5010-004	EUDAMED	Class I	Active
Connection Emp Cosmetica 29r	P-1900-929R	EUDAMED	Class I	Active
Baston Rojo Ergo Blando Aluminio	K-11519-015	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 28l	P-1900-028L	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61201A	EUDAMED	Class I	Active
Ferula De Dedo Spring T/L	X-5017-04	EUDAMED	Class I	Active
Sparta Lp, Categoria 2, 25cm	P-1922-025	EUDAMED	Class I	Active
Soporte Lumbar Rectus Mujer T/M	X-1241-002	EUDAMED	Class I	Active
Funda Cosmetica Izda 44 Cm	P-0074-013	EUDAMED	Class I	Active
Antequino Afo Mujer Dcho	X-8115-012	EUDAMED	Class I	Active
Ferula Stack Distal Carne T/5 (2 Unid)	X-5010-005	EUDAMED	Class I	Active
Baston Gris Ergo Blando Especial Para Corte	K-11510-015S	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 24d	P-1900-024R	EUDAMED	Class I	Active
Soporte Lumbar Rectus Mujer T/L	X-1241-003	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63365C	EUDAMED	Class I	Active
Sparta V, Categoria 3, 29cm	P-1930-029	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63461A	EUDAMED	Class I	Active
Funda Cosmetica Izda 36 Cm	P-0074-011	EUDAMED	Class I	Active
Cosmetieca Pie Protesico, Brown 25r	P-1900-125R	EUDAMED	Class I	Active
Sparta Lp, Categoria 1, 24cm	P-1921-024	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	-P63361A	EUDAMED	Class I	Active
Texton Shirt	X-1400-005	EUDAMED	Class I	Active
Funda Espuma Preform C/Cono Sup Izq 44cm	P-0077-013	EUDAMED	Class I	Active
Sparta Lp, Categoria 2, 23cm	P-1922-023	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62265A	EUDAMED	Class I	Active
Baston Infantil Ergo Azul/Amarillo/Rojo	K-10006-002	EUDAMED	Class I	Active
Tlso Rectus Hombre T/Xxl	X-1742-006	EUDAMED	Class I	Active
Sock Aramo Medio-Largo	P-62465A	EUDAMED	Class I	Active
Cosmetica Plastazote B/K T/M	P-0064-002	EUDAMED	Class I	Active
Soporte Lumbar Rectus Mujer T/S	X-1241-001	EUDAMED	Class I	Active
Baston Azul Ergo Blando Aluminio	K-11518-015	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 26r	P-1900-126R	EUDAMED	Class I	Active
Baston Negro Ergo Blando Aluminio	K-11514-015	EUDAMED	Class I	Active

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