Purgo

FDA UDI

Class II (US FDA UDI)

by Molekule, Inc.

Identity

Trade Name: Purgo FDA UDI
Generic Name: Ultraviolet ambient disinfection light FDA UDI
Device Name: 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 FDA UDI
Model / Reference: PM-100A FDA UDI
Description: 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860006970604 FDA UDI
FDA Product Code: FRA FDA UDI
GMDN Term: Ultraviolet ambient disinfection light FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultraviolet ambient disinfection light

Purgo by Molekule, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultraviolet ambient disinfection light.

UV Smart — UV Smart Technologies B.V. · Class II
The Orthodontic Store — Young Innovations, Inc. · Class I
Hepa-Care® — Abatement Technologies, Inc. · Class II
Hepa-Care® — Abatement Technologies, Inc. · Class II
Hepa-Care® — Abatement Technologies, Inc. · Class II
Molekule Air Pro — Molekule, Inc. · Class II
Molekule — Molekule, Inc. · Class II
Molekule Air Mini — Molekule, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Molekule, Inc.

Sources (1)

FDA UDI 2b548d30-9394-4b42-91d5-8efa0bf2664e 34 fields · synced Jun 8, 2026