Pce, Inc.

Pce, Inc. specializes in single-use vaginal applicators. These devices are designed for one-time use in gynecological procedures and are tailored for specific clinical applications within that field. The focus is on disposable, sterile applicators intended to improve safety and hygiene in medical settings.

Pce, Inc. is based in the United States, which means its devices are subject to U.S. medical device regulations. Since the company’s products fall under Class I classification, they are generally considered low-risk but still require compliance with FDA standards, including registration, listing, and UDI requirements. The U.S. regulatory framework governs their design, manufacturing, and distribution.

Pce, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for healthcare providers and regulators. Listing in this database is a key compliance step for Class I devices in the U.S.

Pce, Inc.’s vaginal applicators are classified as Class I devices under U.S. medical device regulations. This classification is based on their intended use—single-use, low-risk applicators for gynecological procedures—and aligns with FDA criteria for devices that pose minimal risk to patients. Class I devices typically require less stringent premarket review but still must meet basic safety and performance standards.