HEALTHPLUS, LLC

FDA Device Registration & Listing · Asheville, NC, US · Registration 3018609298

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018609298
FEI Number
3018609298
Entity Name
HEALTHPLUS, LLC
City/State/Country
Asheville, NC, US
Establishment Address
430 Ridgefield Court, Asheville, NC 28806, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HealthPlus, LLC (Owner Number: 10081330)
Owner / Operator Contact Address
430 Ridgefield Court, Asheville, NC 28806, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Regard Regard Regard

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2021-04-05
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2025-04-28
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HealthPlus, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09
K102092 Prestige Ameritech PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES 2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018609298. Last updated year: 2026. Please use registration number 3018609298 when referencing this establishment in official correspondence.
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