Question 1

What types of medical devices does Good Doctors Co., Ltd. manufacture?

Accepted Answer

Good Doctors Co., Ltd. specializes in three primary device categories: surgical video cameras, dental and surgical polymerization lamps (such as curing lights), and endodontic apex locators. Their product line includes battery-powered and rechargeable lamps, disposable protective covers for lamps, and accessories like file and lip hooks. These devices are designed for use in dental and surgical settings to enhance precision and efficiency during procedures.

Question 2

Where is Good Doctors Co., Ltd. based, and how does that affect its devices?

Accepted Answer

Good Doctors Co., Ltd. is based in the United States, meaning its devices are subject to U.S. medical device regulations. This includes compliance with FDA requirements for safety, performance, and labeling. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency for authorized devices.

Question 3

Which regulatory registries or databases list Good Doctors Co., Ltd.’s devices?

Accepted Answer

Good Doctors Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, monitoring, and compliance with U.S. medical device regulations. This listing helps healthcare providers and regulators verify the identity and classification of the company’s products.

Question 4

How are Good Doctors Co., Ltd.’s devices classified under FDA regulations?

Accepted Answer

Good Doctors Co., Ltd.’s devices fall under three FDA classification categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Unclassified (U) devices, which may require additional evaluation based on their specific risks. The classification determines the regulatory pathway and controls applied to each device type, ensuring appropriate oversight for their intended use.

Device	Model / Reference	Registries	Class	Status
Battery_Drs Light Claver	CL0200110	FDA UDI	Class II	Active
Dr's Cam_touch	IC-DCBU73	FDA UDI	Class I	Active
Lip Hook(3pccs)	AC0407	FDA UDI	U	Active
Dr's Light CHOICE	CL-DP40	FDA UDI	Class II	Active
File Hook(1pcs)	AC0401	FDA UDI	U	Active
Dr's Light2	CL-DLT30	FDA UDI	Class II	Active
Charger_Drs Light Claver	DC020M1001	FDA UDI	Class II	Active
Charger_DL	DLT030M2001	FDA UDI	Class I	Active
Guide-cap_Drs Light Claver	CL0200210	FDA UDI	Class II	Active
Disposable cover_35x100_wide	IC0600220	FDA UDI	Class I	Active
Disposable cover_60x200_wide	IC0600230	FDA UDI	Class I	Active
Disposable cover_35x100_narrow	IC0600210	FDA UDI	Class I	Active
Disposable cover_60x280_narrow	IC0600250	FDA UDI	Class I	Active
Disposable cover_46x195_wide/100 pcs	IC0600230	FDA UDI	Class I	Active

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