Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021916254

FEI Number

3021916254

Entity Name

CIRCIUS PHARMA AB

City/State/Country

Askim Vastra Gotaland, SE

Establishment Address

34-36 Sodra Langebergsgatan, Askim Vastra Gotaland 43632, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Circius Pharma AB (Owner Number: 10083659)

Owner / Operator Contact Address

34-36 Sodra Langebergsgatan, Askim, SE-O 43632, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223694

PMA Number

N/A

All Registered Proprietary Names

Otovent AutoInflatoin Kit Tinearity

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	2022-03-04
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2025-05-09

Official Correspondent

Maria Carlsson

US Agent Details

Susan Reece Email: susanlreece@invotec.net Phone: (800) 9988580

Related Public Records

Same Entity

Circius Pharma AB

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 3021916254. Last updated year: 2026. Please use registration number 3021916254 when referencing this establishment in official correspondence.