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
Sparta S, Categoria 4, 25cm	P-1934-025	EUDAMED	Class I	Active
Ortesis Dorsiflex.muñeca C/S Art.met.t/M	X-5032-003	EUDAMED	Class I	Active
Sparta S, Categoria 2, 27cm	P-1932-027	EUDAMED	Class I	Active
Ferula Flex.act.art.inter.prox.t/Xs	X-5025-001	EUDAMED	Class I	Active
Connection Emp Cosmetica 26l	P-1900-926L	EUDAMED	Class I	Active
Lso Rectus Mujer T/L	X-1541-004	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Cauca 24l	P-1900-024L	EUDAMED	Class I	Active
Sparta V, Categoria 1, 23cm	P-1911-023	EUDAMED	Class I	Active
Media Femoral T/M-L -par-	P-0068-104	EUDAMED	Class I	Active
Sparta V, Categoria 1, 24cm	P-1911-024	EUDAMED	Class I	Active
Soporte Lumbar Rectus Hombre T/M	X-1242-002	EUDAMED	Class I	Active
Funda Espuma Preform C/Cono Sup Izq 36cm	P-0077-011	EUDAMED	Class I	Active
Sparta Lp, Categoria 4, 28cm	P-1924-028	EUDAMED	Class I	Active
Soporte Dorsal Rectus Hombre T/S	X-1342-001	EUDAMED	Class I	Active
Coonection Emp Cosmetica 24l	P-1900-924L	EUDAMED	Class I	Active
Ferula Extensora De Dedos T/M	X-5016-003	EUDAMED	Class I	Active
Adaptador Grande Lamina Macho	N-1054-200	EUDAMED	Class I	Active
Cosmetica Femoral	P-007	EUDAMED	Class I	Active
Art. Rodilla Hidraulica Black 1028	P-1028-000	EUDAMED	Class I	Active
Muleta Axilar Aluminio	K-12500-1	EUDAMED	Class I	Active
Connection Emp Cosmetica 23r	P-1900-923R	EUDAMED	Class I	Active
Ferula Extensora De Dedos T/S	X-5016-002	EUDAMED	Class I	Active
Art. Rodilla Neumatica Black 1026	P-1026-000	EUDAMED	Class I	Active
Sparta S, Categoria 3, 26cm	p-1933-026	EUDAMED	Class I	Active
Rodillera Suspension Neo-Flex T/0	P-5400-000	EUDAMED	Class I	Active
Sparta V, Categoria 5, 28cm	P-1915-028	EUDAMED	Class I	Active
LANZADERA CENTURION MINI 36mm	P-0100-000	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61363A	EUDAMED	Class I	Active
Art. Rodilla Monocentrica Black 1045	P-1045-000	EUDAMED	Class I	Active
Sock Aramo Ancho Largo	P-63203C	EUDAMED	Class I	Active
Sock Aramo Estrecho-Largo	P-61265C	EUDAMED	Class I	Active
Soporte Dorsal Rectus	X-1340-000	EUDAMED	Class I	Active
Soporte Lumbar Rectus Hombre T/L	X-1242-003	EUDAMED	Class I	Active
Sparta Lp, Categoria 3, 27cm	P-1923-027	EUDAMED	Class I	Active
Aria Valvula Auto-Expulsion Con Pulsador	P-9014-500	EUDAMED	Class I	Active
Surtido Stack Distal Carne (30 Unid)	X-5010-000	EUDAMED	Class I	Active
Rodillera De Gel Suspension Aramo T/Xl	P-3500-600	EUDAMED	Class I	Active
Tlso Rectus Hombre T/Xl	X-1742-005	EUDAMED	Class I	Active
Sparta V, Categoria 4, 29cm	P-1914-029	EUDAMED	Class I	Active
Funda Cosmet.c/Cono Sup Dcha 44cm	P-0075-003	EUDAMED	Class I	Active
Ferula Ext.act.art.inter.prox.t/L	X-5026-004	EUDAMED	Class I	Active
Antequino Taeme Izdo T/P	X-8116-001	EUDAMED	Class I	Active
Ortesis Dorsiflex.muñeca C/S Art.met.t/L	X-5032-004	EUDAMED	Class I	Active
Lso Rectus Mujer T/M	X-1541-003	EUDAMED	Class I	Active
Cosmetica Tibial Cuadrada	P-0063-000	EUDAMED	Class I	Active
Sparta Lp, Categoria 3, 28 Cm	P-1923-028	EUDAMED	Class I	Active
Sparta S, Categoria 5, 26cm	P-1935-026	EUDAMED	Class I	Active
Ferula Extensora T/G	X-5020-004	EUDAMED	Class I	Active
Lso Rectus	X-1540-000	EUDAMED	Class I	Active
Cosmetica Pie Protesico, Brown 27r	P-1900-127R	EUDAMED	Class I	Active

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