Aga Plastic Ind. Com. Ltda.
US Last updated 23 May 2026
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- Devices
- 2
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Agachamber Spacer Ref K101348
Aromatic And Flavored Tongue Depressor Ref K992995
FDA establishments
- Agaplastic Ind. Com. Ltda. RIO DE JANEIRO · BR FEI 3003080016
What Aga Plastic Ind. Com. Ltda. makes
Aga Plastic Ind. Com. Ltda. manufactures medical devices including the AGACHAMBER SPACER, a device used in respiratory therapy to improve medication delivery, and AROMATIC AND FLAVORED TONGUE DEPRESSORS, which assist in oral hygiene procedures by reducing gag reflexes.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with records submitted via the 510(k) pathway. These products are listed in the FDA’s regulatory database and are based in the United States.
Frequently asked questions
What types of medical devices does Aga Plastic Ind. Com. Ltda. manufacture?
Aga Plastic Ind. Com. Ltda. produces medical devices such as the AGACHAMBER SPACER, which is used in respiratory therapy to enhance medication delivery efficiency, and AROMATIC AND FLAVORED TONGUE DEPRESSORS, designed to aid oral hygiene by minimizing gag reflexes during procedures. These devices serve distinct clinical purposes in patient care.
Where is Aga Plastic Ind. Com. Ltda. based, and how does that affect its regulatory standing?
Aga Plastic Ind. Com. Ltda. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s regulatory database, specifically through the 510(k) pathway, indicating they meet the agency’s requirements for market authorization under U.S. law.
Which regulatory registries or databases list Aga Plastic Ind. Com. Ltda.’s devices?
Aga Plastic Ind. Com. Ltda.’s devices are recorded in the FDA’s 510(k) database, a public registry that tracks medical devices authorized via the 510(k) premarket notification process. This listing confirms compliance with FDA requirements for specific device classifications.
How are Aga Plastic Ind. Com. Ltda.’s devices classified under FDA regulations?
Aga Plastic Ind. Com. Ltda.’s devices fall into Class I and Class II categories under FDA regulations. Class I devices generally pose minimal risk and may be exempt from strict premarket controls, while Class II devices require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. The 510(k) pathway is used for Class II devices to demonstrate substantial equivalence to a predicate device.
Information
- Country
- US