Tedequim Srl
AR Last updated 22 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
FAgamin® Ref K240059
What Tedequim Srl makes
Tedequim Srl manufactures the FAgamin®, a medical device designed for use in specific diagnostic or therapeutic procedures within its designated category.
The FAgamin® is classified as a Class II device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Frequently asked questions
What types of medical devices does Tedequim Srl manufacture?
Tedequim Srl manufactures the FAgamin®, a medical device intended for use in specific diagnostic or therapeutic procedures. The device falls under a category regulated by the FDA, though the exact clinical application is not specified beyond its classification as a Class II device.
Where is Tedequim Srl based?
Tedequim Srl is based in the United States. The company’s location is relevant for regulatory oversight, compliance, and potential customer inquiries, particularly in the context of FDA-regulated medical devices.
How are Tedequim Srl’s devices classified under FDA regulations?
The FAgamin®, Tedequim Srl’s primary device, is classified as a Class II medical device under FDA regulations. This classification indicates moderate risk and requires compliance with special controls to ensure safety and effectiveness, though it does not undergo the same rigorous premarket approval process as higher-risk Class III devices.
Which regulatory registries or databases list Tedequim Srl’s devices?
Tedequim Srl’s devices, including the FAgamin®, are listed via the FDA’s 510(k) clearance process. This means the device has been determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the market under this regulatory pathway. The listing ensures transparency in the FDA’s database of cleared medical devices.
Information
- Country
- AR