Earflo Company

FDA Device Registration & Listing · Pittsburgh, PA, US · Registration 3043739646

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
3043739646
FEI Number
3043739646
Entity Name
Earflo Company
City/State/Country
Pittsburgh, PA, US
Establishment Address
203 Lothrop St, Suite 500, Pittsburgh, PA 15213, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Earflo Inc. (Owner Number: 10095482)
Owner / Operator Contact Address
848 Knoll Drive, San Carlos, CA 94070, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252751
PMA Number
N/A

All Registered Proprietary Names

Earflo EF001 Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MJV Device, Inflation, Middle Ear Unknown Class U N/A 2026-03-18

Official Correspondent

Intan Oldakowska

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Similar Registrations

Registration Number Establishment Name Location
3008719017 SUMMIT MEDICAL LLC Saint Paul, MN, US
3006157842 ASIA CONNECTION CO., LTD. New Taipei City, TW
3021636313 ENTECH ELECTRONICS TRADE (SHENZHEN) COMPANY LTD. Shenzhen Guangdong, CN
3021916254 CIRCIUS PHARMA AB Askim Vastra Gotaland, SE
2954718 NEILMED PHARMACEUTICALS, INC. Santa Rosa, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043739646. Last updated year: 2026. Please use registration number 3043739646 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.