Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006288727

FEI Number

3006288727

Entity Name

SIBEL S.A.

City/State/Country

Sabadell Barcelona, ES

Establishment Address

Raimon Casellas, 6-8., Sabadell Barcelona 08205, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SIBEL S.A. (Owner Number: 10046082)

Owner / Operator Contact Address

Raimon Casellas, 6-8., Sabadell, ES-B 08205, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Astra 300

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2014-01-31

Official Correspondent

Antoni Pico Genestar

US Agent Details

Michael Boyle Business: SDI Diagnostics, Inc. Email: mjboyle@sdidiagnostics.com Phone: (508) 2387033

Related Public Records

Same Entity

SIBEL S.A.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006288727. Last updated year: 2026. Please use registration number 3006288727 when referencing this establishment in official correspondence.