Is this your brand? Sign in to claim ownership.

Orfit Industries

Belgium·BE-MF-000007872

Last updated September 18, 2026

About

As leaders in thermoplastic innovations we develop and produce precise and reliable thermoplastic materials for medical devices.

From the manufacturer's own website. Source

Device	Model / Reference	Registries	Class	Status
Shap3d	3DF/W/1.75/1	EUDAMED	Class I	Active
Shap3d	3DF/W/2.85/0.5	EUDAMED	Class I	Active
Thermofit	K151946	FDA 510(k)	Class II	Active
Raycast Immobilization Systems Hardware And Thermoplastic Materials	K991319	FDA 510(k)	Class II	Active
Shap3d	3DF/OR/2.85/0.5	EUDAMED	Class I	Active
Shap3d	3DF/B/1.75/1	EUDAMED	Class I	Active
Shap3d	3DF/OR/1.75/0.5	EUDAMED	Class I	Active
Shap3d	3DF/W/1.75/0.5	EUDAMED	Class I	Active
Shap3d	3DF/OR/1.75/1	EUDAMED	Class I	Active
Thermoplastic material for orthotics and prosthetics.	37SS/4480B	EUDAMED	Class I	Active
Shap3d	3DF/BL/1.75/0.5	EUDAMED	Class I	Active
The AIO Solution® (All-in-One Patient Positioning Solution)	38133	EUDAMED	Class I	Active
The AIO Solution® (All-in-One Patient Positioning Solution)	38001	EUDAMEDFDA UDI	Class I	Active
Shap3d	3DF/B/2.85/1	EUDAMED	Class I	Active
Raycast® High Precision – Thermoplastic Bolus Material	703011/1	EUDAMEDFDA UDI	Class I	Active
Shap3d	3DF/BL/2.85/1	EUDAMED	Class I	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Establishments registered with the FDA under this company group, matched by name.