Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011797532

FEI Number

3011797532

Entity Name

CASCINATION

City/State/Country

BERN, CH

Establishment Address

Steigerhubelstrasse 3, BERN 3008, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CASCINATION AG (Owner Number: 10049564)

Owner / Operator Contact Address

Steigerhubelstrasse 3, Bern, CH-BE 3008, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203486

PMA Number

N/A

All Registered Proprietary Names

Otoplan 2 OTOPLAN Otoplan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QQE	Image Management Software For Planning Of Otologic And Neurotologic Procedures	Radiology	Class 2	892.2050	2022-06-30
QQE	Image Management Software For Planning Of Otologic And Neurotologic Procedures	Radiology	Class 2	892.2050	2025-06-10
QQE	Image Management Software For Planning Of Otologic And Neurotologic Procedures	Radiology	Class 2	892.2050	2021-11-15

Official Correspondent

Gordana Salleles

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

CASCINATION AG

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

View Entity Profile →

Similar Registrations

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3042364673	NEURALYTIX LLC	Fruita, CO, US
3043617526	AD SCIENTIAM	Paris Ile-de-France, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011797532. Last updated year: 2026. Please use registration number 3011797532 when referencing this establishment in official correspondence.