Question 1

What types of medical devices does Footlogics Europe B.V. manufacture?

Accepted Answer

Footlogics Europe B.V. specializes in prefabricated orthotic insoles, which are designed to provide general foot support. These insoles come in various categories such as casual, sport, comfort, and high-heel variants. They are intended to help alleviate foot discomfort, knee pain, and back pain by offering cushioning and arch support. Examples include insoles like the FOOTLOGICS CASUAL INSOLE M or the FOOTLOGICS SPORT INSOLE XL.

Question 2

Where is Footlogics Europe B.V. based, and what regulatory requirements do they follow?

Accepted Answer

Footlogics Europe B.V. is based in the Netherlands. Their devices are classified as Class I medical devices, which means they are subject to the EU’s regulatory framework for medical devices. While the company operates within the EU, individual devices must comply with relevant EU regulations to be authorized for use.

Question 3

Are Footlogics Europe B.V.’s devices listed in any regulatory registries?

Accepted Answer

Yes, Footlogics Europe B.V.’s devices are listed in the EU’s eudamed registry. This database is used to track medical devices authorized for placement on the EU market, ensuring transparency and traceability for regulatory oversight.

Question 4

How are Footlogics Europe B.V.’s orthotic insoles classified under EU regulations?

Accepted Answer

Footlogics Europe B.V.’s orthotic insoles fall under Class I classification in the EU. This classification is typically assigned to low-risk devices, such as prefabricated insoles, which are intended for general foot support without significant health risks. Classification determines the regulatory pathway for authorization, but it does not imply approval—only that the device must meet specific EU requirements.

Device	Model / Reference	Registries	Class	Status
Footlogics Casual Insole M	1059MC M	EUDAMED	Class I	Active
Footlogics Sport Insole Xs	1069.6VF XS	EUDAMED	Class I	Active
Footlogics Comfort Insole Xl	1069.4CA XL	EUDAMED	Class I	Active
Footlogics Sensi Insole S	1053APS S	EUDAMED	Class I	Active
Footlogic Sensi Insole Xs	1053APS XS	EUDAMED	Class I	Active
Footlogics Sensi Insole M	1053APS	EUDAMED	Class I	Active
Footlogics Sport Insole Xl	1069.9VF XL	EUDAMED	Class I	Active
Footlogics Sport Insole Xl	1069.6VF XL	EUDAMED	Class I	Active
Footlogics Sensi Insole M	1053APS M	EUDAMED	Class I	Active
Footlogics Comfort Insole M	1069.4CA M	EUDAMED	Class I	Active
Footlogics High Heel Insole Xs	2008N	EUDAMED	Class I	Active
Footlogics Comfort Plus Insole M	1069.4SVP M	EUDAMED	Class I	Active
Footlogics Kids Insole	1057 KIDS	EUDAMED	Class I	Active
Footlogics Casual Insole S	1059MC S	EUDAMED	Class I	Active
Footlogics Casual Insole Xs	1059MC XS	EUDAMED	Class I	Active
Footlogics Sport Insole L	1069.9VF L	EUDAMED	Class I	Active
Footlogics Casual Insole M	1059MC M	EUDAMED	Class I	Active
Footlogics Comfort Insole M	1069.4CA M	EUDAMED	Class I	Active
Footlogics High Heel Insole Xs	2008N XS	EUDAMED	Class I	Active
Footlogics Comfort Plus Insole Xs	1069.4SVP XS	EUDAMED	Class I	Active
Footlogics Comfort Insole Xs	1069.4CA XS	EUDAMED	Class I	Active
Footlogics Comfort Plus Insole L	1069.4SVP L	EUDAMED	Class I	Active
Footlogics Sport Insole S	1069.6VF S	EUDAMED	Class I	Active
Footlogics Casual Insole Xl	1059MC XL	EUDAMED	Class I	Active
Footlogics Comfort Insole S	1069.4CA S	EUDAMED	Class I	Active
Footlogics High Heel Insole M	2008N M	EUDAMED	Class I	Active
Footlogics Comfort Insole Xl	1069.4CA XL	EUDAMED	Class I	Active
Footlogics Sport Insole Xs	1069.6VF XS	EUDAMED	Class I	Active
Footlogics Sport Insole M	1069.6VF M	EUDAMED	Class I	Active
Footlogcs Comfort Plus Insole Xs	1069.4SVP XS	EUDAMED	Class I	Active
Footlogics Sensi Insole Xs	1053APS XS	EUDAMED	Class I	Active
Footlogics Comfort Insole S	1069.4CA S	EUDAMED	Class I	Active
Footlogics Casual Insole L	1059MC L	EUDAMED	Class I	Active
Footlogics Sensi Insole L	1053APS L	EUDAMED	Class I	Active
Footlogics Comfort Plus Insole L	1069.4SVP L	EUDAMED	Class I	Active
Footlogics Casual Insole Xl	1059MC XL	EUDAMED	Class I	Active
Footlogics Sport Insole M	1069.9VF M	EUDAMED	Class I	Active
Footlogics High Heel Insole S	2008N S	EUDAMED	Class I	Active
Footlogics Comfort Plus Insole Xl	1069.4SVP XL	EUDAMED	Class I	Active
Footlogics Comfort Plus Insole S	1069.4SVP S	EUDAMED	Class I	Active
Footlogics Comfort Insole L	1069.4CA L	EUDAMED	Class I	Active
Footlogics Sensi Insole L	1053APS L	EUDAMED	Class I	Active
Footlogics Sensi Insole Xl	1053APS XL	EUDAMED	Class I	Active

Footlogics Europe B.V.

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