ARCHIVED 3. List of Medical Devices for Exceptional Importation and Sale [2020-06-01]

Notice to reader:

This is an archived list. Please refer to the most current version of this list.

Medical devices included on this list are called "designated medical devices" and are eligible for the exceptional importation and sale provisions provided for in the Interim Order.

Supersedes: 2020-05-21
Date issued: 2020-06-01

Access archived versions of this list.

List of Medical Devices for Exceptional Importation and Sale

Medical Device	Medical Device Category	Country of Manufacture	Name of Manufacturer	MDEL/MDL number	Date
Non-Woven Face Masks	I	China	Shenzhen Delong Huale Electronic Co. Ltd	MDEL 2332	2020-04-10
Non-Woven Face Masks	I	China	Xiantao Xingrong Protective Products Co., Ltd.	MDEL 2332	2020-04-10
Face Mask for Single Use	I	China	Wuxi Yushou Medical Appliances Co., Ltd.	MDEL 11700	2020-04-10
N95 Respirators	I	China	Suzhou Fangtian Industries Co., Ltd.	MDEL 11700	2020-04-11
N95 Respirators	I	China	Makrite Industries Inc.	MDEL 11700	2020-04-11
Medical Grade Face Masks	I	China	V&Q Manufacturing Corporation	MDEL 9174	2020-04-17
Isolation Gowns	I	China	Wuhan Orient Honest International Trade Co., Ltd	MDEL11707	2020-04-17
Face Mask 3-Ply with Ear Loop / Tie	I	China	Shandong Zhushi Pharmaceutical Group Co., Ltd.	MDEL 6151	2020-04-17
Surgical Masks	I	China	Xiantao Xingrong Protective Products Co., Ltd.	MDEL 6732	2020-04-17
Face Masks	I	China	Halemann Technology Co., Ltd	MDEL 11765	2020-04-17
3-Ply Face Masks, with Earloops	I	China	Hubei Fullcare Protective Products Co., Ltd.	MDEL 1841	2020-04-17
Newport HT-50 Ventilator	III	USA	Newport Medical Instruments Inc.	MDEL 11862	2020-04-17