Who else makes this device?

Name: Purgo
Brand: Purgo

General Hospital › MiscellaneousPurifier, Air, Ultraviolet, Medical

Purgo

Purgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria, viruses, fungi,…

Registry build 21.09.26

Purgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria, viruses, fungi, and particulate matter in air. Purgo may be used in medical facilities and commercial home healthcare environments

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code FRA
Manufacturer	City	Province	Registered as	Device types
Guangzhou Ajax Medical Equipment Co Ltd	Guangzhou	Guangdong	Manufacturer	13
Shenzhen Airgle Corporation Limited	Shenzhen	Guangdong	Manufacturer	4

Record

Regulatory record for Purgo
Listed by	Molekule Group, Inc., United States
FDA product code	FRA
Device type	Purifier, Air, Ultraviolet, Medical
Device class	Class 2
Regulation	21 CFR 880.6500
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2023-08-11
Record revised	2023-10-18 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Purgo
Catalogue number	Size	Status
PM-100A		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Airgle	Airgle Corporation	10
RGF-BioControls	RGF Environmental Group, Inc	9
Aerobiotix	Aerobiotix USA	5
ADS	Guangzhou Ajax Medical Equipment Co Ltd	5
Molekule Air Mini +	Molekule Group, Inc.	2
Molekule	Molekule Group, Inc.	1
The Pyure Company	The Pyure Company Inc	1
ActivePure Medical Guardian	Activepure Medical LLC	1
RGS mini	Genesis AIR, Inc.	1
Medical Guardian	Aerus Medical, LLC	1
RGS	Genesis AIR, Inc.	1
Molekule Air Pro	Molekule Group, Inc.	1

Showing 12 of 13. All products under Purifier, Air, Ultraviolet, Medical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K211194	2021-08-20
K202339	2021-02-23
K200500	2020-04-15

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.