Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020763244

FEI Number

3020763244

Entity Name

AETHER BIOMEDICAL SP. Z O.O.

City/State/Country

Poznan Wielkopolskie, PL

Establishment Address

Mostowa, 11, Poznan Wielkopolskie 61-854, PL

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Aether Biomedical Sp. z o.o. (Owner Number: 10082990)

Owner / Operator Contact Address

Mostowa 11, Poznan, PL-30 62-080, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aether Digital Platform Aether MyoSense ZEUS Aether Battery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHF	Monitor, Orthotic/Prosthetic	Physical Medicine	Class 1	890.3025	2022-06-22
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2021-10-19

Official Correspondent

Marlena Swider-Biedziak

US Agent Details

Sarra Mullen Business: Aether US Inc Email: sarra.mullen@aetherbiomedical.com Phone: (302) 1470823

Related Public Records

Same Entity

Aether Biomedical Sp. z o.o.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020763244. Last updated year: 2026. Please use registration number 3020763244 when referencing this establishment in official correspondence.