Question 1

What types of devices does Fidia Farmaceutici manufacture?

Accepted Answer

Fidia Farmaceutici manufactures vaginal lubricants and moisturizing products such as gels and suppositories, synovial fluid supplementation media for joint injection, wound hydrogel dressings, and platelet concentration preparation kits. These product types are derived directly from the device categories and example devices provided in the data, which include HYALO GYN Vaginal Hydrating Gel, TRILURON, Hyalo4 Care Hydrogel, and RICHPLAT ORTHO PRP SYSTEM.

Question 2

Where is Fidia Farmaceutici based?

Accepted Answer

Fidia Farmaceutici is based in the United States, as explicitly stated in the SUMMARY section of the device data, which confirms the company's location without referencing any history, size, staff, or certifications.

Question 3

In which regulatory registries are Fidia Farmaceutici's devices listed?

Accepted Answer

Fidia Farmaceutici's devices are listed in the FDA PMA and FDA UDI registries, as indicated in the LISTED IN field of the device data. This listing reflects where the devices are registered, not that the company itself is approved or cleared.

Question 4

How are Fidia Farmaceutici's devices classified?

Accepted Answer

Fidia Farmaceutici's devices are classified as Class II, Class III, and unclassified (U), according to the DEVICE CLASSES field in the device data. Classification applies to individual devices based on risk, not the company as a whole, and the presence of multiple classes reflects the range of device types they manufacture.

Device	Model / Reference	Registries	Class	Status
Hyalgan® Sodium Hyaluronate 2mL Vial	89122-0724-12	FDA UDI	Class III	Unknown
Richplat Ortho Prp System	FPRP20	FDA UDI	Class II	Active
Triluron	89122-0879-01	FDA UDI	Class III	Active
TriLURON	M71389122087901A13	FDA UDI	Class III	Unknown
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe	89122-4966-30	FDA UDI	Class III	Unknown
Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL	89122-0724-20	FDA UDI	Class III	Active
Hyalo4 Care Hydrogel, 25g	49444-0025-08	FDA UDI	U	Active
Hyalo4 Care Hydrogel, 100g	49444-0100-35	FDA UDI	U	Active
HYALO GYN Vaginal Hydrating Gel, 30g Tube - Made without Parabens	179704	FDA UDI	Class II	Active
TriLURON	M71389122087901SAM1A	FDA UDI	Class III	Unknown
Hyalo4 Care Clear Hydrogel, 100g	49429-0100-35	FDA UDI	U	Active
Hyalo4 Care Clear Hydrogel, 30g	49429-0030-10	FDA UDI	U	Active
HYALO GYN Vaginal Moisturizing Suppositories	10000404	FDA UDI	Class II	Active
Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL	89122-0724-20	FDA UDI	Class III	Unknown
HYALO GYN Vaginal Moisturizing Suppositories Sample	10000405	FDA UDI	Class II	Active
vH Essentials Moisturizing Vaginal Suppositories	5396	FDA UDI	Class II	Active
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack	89122-0496-01	FDA UDI	Class III	Active
HYALO GYN Vaginal Hydrating Gel, 30g Tube	179604	FDA UDI	Class II	Active
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe	89122-0496-63	FDA UDI	Class III	Unknown
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe	FID185704	FDA UDI	Class III	Unknown
HYALO GYN Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample	379704	FDA UDI	Class II	Active
HYALO GYN Vaginal Hydrating Gel, 10g Tube	379604	FDA UDI	Class II	Active
Hyalgan® Sodium Hyaluronate 2mL Vial	89122-0724-12	FDA UDI	Class III	Active
CVS Health Moisturizing Vaginal Suppositories	833306	FDA UDI	Class II	Active
HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan)	P150010	FDA PMA	Class III	Active

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