PIGEON INDUSTRIES (THAILAND) COMPANY LIMITED

Pigeon Industries primarily manufactures reusable nipple shielding teats. These devices are specifically designed for infant feeding to protect nipples during breastfeeding by acting as a barrier between the infant’s mouth and the mother’s skin. The focus is on a single category of reusable nipple protection.

Pigeon Industries is based in the United States. The company’s location is relevant for understanding regulatory jurisdiction, as its devices fall under U.S. regulatory oversight.

Pigeon Industries’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory requirements.

Pigeon Industries’ nipple shielding teats are classified as Class I devices under FDA regulations. This classification applies to devices posing minimal risk, often exempt from pre-market approval but still subject to general controls like good manufacturing practices and labeling requirements.