Question 1

What types of medical devices does OrtoProfil Prod Romania SRL primarily manufacture?

Accepted Answer

OrtoProfil Prod Romania SRL specializes in prefabricated orthotic insoles, which are designed to support and correct foot alignment. Their product range includes general-use insoles like the ProfiTEX PodoCare ORTOMED FP40 and ORTOMED MT25, as well as sports-specific insoles such as the ProfiTEX PodoCare Sport SDR 26 and SBI 30. These devices are intended to address common foot-related issues, such as arch support or shock absorption during physical activity.

Question 2

Where is OrtoProfil Prod Romania SRL based, and how does this affect its regulatory standing?

Accepted Answer

OrtoProfil Prod Romania SRL is based in Romania, which means its devices are subject to EU Medical Device Regulation (MDR) requirements. Since all its listed devices fall under Class I, they are considered low-risk and require compliance with basic safety and performance standards. The company registers its devices in the EUDAMED database, which is the official EU portal for tracking medical devices, ensuring transparency and traceability across the European market.

Question 3

Are OrtoProfil Prod Romania SRL’s devices listed in any regulatory registries, and why does this matter?

Accepted Answer

Yes, OrtoProfil Prod Romania SRL’s devices are registered in EUDAMED, the European Union’s medical device registry. This matters because EUDAMED serves as an official database for tracking devices that comply with EU regulations, including their classification, manufacturer details, and market surveillance information. Listing in EUDAMED helps healthcare professionals, regulators, and patients verify the legitimacy and compliance status of the devices, particularly for Class I products that still require proper documentation and traceability.

Question 4

How are OrtoProfil Prod Romania SRL’s devices classified under EU regulations, and what does this classification imply?

Accepted Answer

OrtoProfil Prod Romania SRL’s devices are classified as Class I under the EU Medical Device Regulation. This classification is determined by factors such as the intended use and risk level of the product. Class I devices are generally considered low-risk, such as prefabricated orthotic insoles, which do not require invasive procedures or pose significant health risks. However, even Class I devices must still meet basic safety and performance requirements, including proper labeling, manufacturing controls, and compliance with applicable EU directives or regulations.

Device	Model / Reference	Registries	Class	Status
ProfiTEX Lombosacral comp VIII	4X.CO-120.8-VIII	EUDAMED	Class I	Active
ProfiTEX PodoCare RIGIDUSM 45	4STO.RIGIDUS MEN-45	EUDAMED	Class I	Active
ProfiTEX Carpieră cu atelă V	4X.O-151-V	EUDAMED	Class I	Active
ProfiTEX PodoCare ORTOMED EC36	4T.S-200-EC-36	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S B 30	7P.T PED S B-30	EUDAMED	Class I	Active
ProfiTEX PodoCare ORTOMED FP33	4T.S-200-FP-33	EUDAMED	Class I	Active
ProfiTEX sacro-iliacă V	4X.AHI-024-V	EUDAMED	Class I	Active
ProfiTEX PodoCare HEEL SPUR 41	4STO.HEEL SPUR-41	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S F 25	7P.T PED S F-25	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S T 40	7P.T PED S T-40	EUDAMED	Class I	Active
ProfiTEX Ghete 18	4I.GO 031-18	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport TT 30	4T.T-20-30	EUDAMED	Class I	Active
ProfiTEX „Ham de memorie” V	4X.HM-26-V	EUDAMED	Class I	Active
ProfiTEX Lombosacral-Lombs VI	4X.L-023-VI	EUDAMED	Class I	Active
ProfiTEX PodoCare ORTOMED EC25	4T.S-200-EC-25	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S T 32	7P.T PED S T-32	EUDAMED	Class I	Active
ProfiTEX PodoCare RIGIDUSW 38	4STO.RIGIDUS WOMEN-38	EUDAMED	Class I	Active
ProfiTEX Ghete 25	4I.GO 031-25	EUDAMED	Class I	Active
ProfiTEX PodoCare HEEL SPUR 44	4STO.HEEL SPUR-44	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S F 47	7P.T PED S F-47	EUDAMED	Class I	Active
ProfiTEX PodoCare FULL SHELL37	4STO.FULL SHELL-37	EUDAMED	Class I	Active
ProfiTEX PodoCare ORTOMED EC33	4T.S-200-EC-33	EUDAMED	Class I	Active
ProfiTEX PodoCare ORTOMED PP45	4T.S-200-PP-45	EUDAMED	Class I	Active
ProfiTEX „Ham de memorie” IV	4X.HM-26-IV	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport SDR 39	7P.T PED S DR-39	EUDAMED	Class I	Active
ProfiTEX PodoCare HEEL SPUR 43	4STO.HEEL SPUR-43	EUDAMED	Class I	Active
ProfiTEX PodoCare FLAT SHELL38	4STO.FLAT SHELL-38	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S F 32	7P.T PED S F-32	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S A 30	7P.T PED S A-30	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport SDR 40	7P.T PED S DR-40	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S B 41	7P.T PED S B-41	EUDAMED	Class I	Active
ProfiTEX PodoCare FLAT SHELL36	4STO.FLAT SHELL-36	EUDAMED	Class I	Active
ProfiTEX Lombosacral comp IV	4X.CO-120.8-IV	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport TT 26	4T.T-20-26	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport TT 28	4T.T-20-28	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S B 26	7P.T PED S B-26	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S F 42	7P.T PED S F-42	EUDAMED	Class I	Active
ProfiTEX PodoCare ELEGANCEW 42	4STO.ELEGANCE WOMEN-42	EUDAMED	Class I	Active
ProfiTEX sacro-iliacă VI	4X.AHI-024-VI	EUDAMED	Class I	Active
ProfiTEX PodoCare ORTOMED MT39	4T.S-200-MT-39	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S F 43	7P.T PED S F-43	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S A 39	7P.T PED S A-39	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S T 38	7P.T PED S T-38	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport S B 42	7P.T PED S B-42	EUDAMED	Class I	Active
ProfiTEX PodoCare ORTOMED FP44	4T.S-200-FP-44	EUDAMED	Class I	Active
ProfiTEX „Ham de memorie” II	4X.HM-26-II	EUDAMED	Class I	Active
Orteză corectoare de statică a piciorului	4STO.KID-35	EUDAMED	Class I	Active
ProfiTEX PodoCare Sport SBI 39	7P.T PED S BI-39	EUDAMED	Class I	Active
ProfiTEX Hallus-Valgus M	4X.388-M	EUDAMED	Class I	Active
ProfiTEX de abductie copii I	4X.CHA028-I	EUDAMED	Class I	Active

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