Hepa-Care®

FDA UDI

Class II (US FDA UDI)

by Abatement Technologies, Inc.

Identity

Trade Name: HEPA-CARE® FDA UDI
Generic Name: High-efficiency filter air cleaner, mobile FDA UDI
Device Name: HEPA-CARE® Digital Portable Unit with UV, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, single phase. Electrical Safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Made in Canada FDA UDI
Model / Reference: HC400FDUV FDA UDI
Description: HEPA-CARE® Digital Portable Unit with UV, 120 Volt, 2 Amp, 60 Hz. Motor thermally protected, single phase. Electrical Safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Made in Canada FDA UDI

Identifiers

Primary DI / UDI-DI: 00818261021401 FDA UDI
510(k) Number: K984116 FDA UDI
FDA Product Code: FRF FDA UDI
GMDN Term: High-efficiency filter air cleaner, mobile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5045 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: High-efficiency filter air cleaner, mobile

Hepa-Care® by Abatement Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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

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Manufacturer

Manufacturer: Abatement Technologies, Inc.

Sources (1)

FDA UDI 975abb74-54db-4a7b-9c0c-85199ab19c77 35 fields · synced Jun 1, 2026