SEFAM MEDICAL

FDA Device Registration & Listing · Villers-les-Nancy Meurthe-et-Moselle, FR · Registration 3013620584

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013620584
FEI Number
3013620584
Entity Name
SEFAM MEDICAL
City/State/Country
Villers-les-Nancy Meurthe-et-Moselle, FR
Establishment Address
10 allee Pelletier-Doisy, Villers-les-Nancy Meurthe-et-Moselle 54600, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SeFam Medical (Owner Number: 10089599)
Owner / Operator Contact Address
10 allee Pelletier-Doisy, Villers-lès-Nancy, FR-NOTA 54600, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080439
PMA Number
N/A

All Registered Proprietary Names

Sandman Auto without Humidifier Model M-114801-114802-US

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

SeFam Medical
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
K792722 Novametrix Medical Systems, Inc. NOVAMETRIX CPAP NASAL CANNULA 1980-01-24
K082979 Resmed, Ltd. S8 ADVANCE 2009-01-02
K203126 Resmed Pty , Ltd. S10 Kirra 2020-12-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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3042507287 3B MEDICAL INC W Jefferson, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013620584. Last updated year: 2026. Please use registration number 3013620584 when referencing this establishment in official correspondence.
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