ACME FILTER MASK INC.

FDA Device Registration & Listing · New Taipei City, TW · Registration 3007053183

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
3007053183
FEI Number
3007053183
Entity Name
ACME FILTER MASK INC.
City/State/Country
New Taipei City, TW
Establishment Address
No.57, Hu Shan Rd. Yi Ko Town,, New Taipei City 23941, TW
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
ACME Filter Mask Inc. (Owner Number: 10030786)
Owner / Operator Contact Address
No.57, Hu Shan Rd. Yi Ko Town,, New Taipei City, TW-NWT 23941, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123115
PMA Number
N/A

All Registered Proprietary Names

Face Shield Surgical Mask

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-04-08
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-10

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

ACME Filter Mask Inc.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007053183. Last updated year: 2026. Please use registration number 3007053183 when referencing this establishment in official correspondence.
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