Sunnycraft Philippines, Inc.
PH Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Sunglasses Ref K931408
What Sunnycraft Philippines, Inc. makes
Sunnycraft Philippines, Inc. manufactures sunglasses designed for general eye protection and UV radiation blocking.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Sunnycraft Philippines, Inc. manufacture?
Sunnycraft Philippines, Inc. specializes in manufacturing sunglasses that provide general eye protection and block UV radiation. These products are designed to safeguard the eyes from harmful ultraviolet light exposure, making them suitable for everyday use.
Where is Sunnycraft Philippines, Inc. based?
Sunnycraft Philippines, Inc. is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs its medical device classifications and compliance requirements.
How are Sunnycraft Philippines, Inc.’s devices classified under FDA regulations?
Sunnycraft Philippines, Inc.’s sunglasses are classified as Class I medical devices by the FDA. This classification applies to devices posing minimal risk to users, such as those intended for general eye protection and UV radiation blocking. Class I devices typically undergo 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Sunnycraft Philippines, Inc.’s devices?
Sunnycraft Philippines, Inc.’s devices are listed in the FDA’s 510(k) database, which tracks medical devices that have undergone the 510(k) premarket notification process. This registry confirms the device’s compliance with FDA requirements for Class I devices, ensuring transparency for healthcare providers and regulators.
Information
- Country
- PH