Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000154583

FEI Number

1000154583

Entity Name

ELFO AG

City/State/Country

Sachseln Obwalden, CH

Establishment Address

Edisriederstrasse 106, Sachseln Obwalden 6072, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

elfo ag (Owner Number: 10058377)

Owner / Operator Contact Address

Edisriederstrasse 106, Sachseln, CH-OW 6072, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2018-09-10
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2018-09-07

Official Correspondent

Dominic Zajonc

US Agent Details

Joy Tobin Business: ndd Medical Technologies Email: jtobin@nddmed.com Phone: (978) 4700923

Related Public Records

Same Entity

elfo ag

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 1000154583. Last updated year: 2026. Please use registration number 1000154583 when referencing this establishment in official correspondence.