IT DR. GAMBERT GMBH

FDA Device Registration & Listing · WISMAR Mecklenburg-Western Pomerania, DE · Registration 9613449

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
9613449
FEI Number
3002739067
Entity Name
IT DR. GAMBERT GMBH
City/State/Country
WISMAR Mecklenburg-Western Pomerania, DE
Establishment Address
HINTER DEM CHOR 21, WISMAR Mecklenburg-Western Pomerania 23966, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IT DR. GAMBERT GMBH (Owner Number: 9042424)
Owner / Operator Contact Address
HINTER DEM CHOR 21, --, WISMAR, M-V, DE-MV 23966, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K002384
PMA Number
N/A

All Registered Proprietary Names

M-43GE M-07T M-15 M-15T incl. Flow Diverter MLF-04 MLF-80 M-04 M-43T M-14T MLF-42HL M-16HTT M-16VT M-01L2 M-43 M-43T Doppelpack M-14 M-12 Doppelpack M-15TL incl. Flow Diverter MLF-80HL MLF-03 M-07S MLF-45H M-03T M-08 M-05 M-25T MLF-16HL M-04T M-25 incl. Flow Diverter M-07ST M-43GE Dual Pack M-15M M-44 M-02L2 M-18T M-09T MLF-12A MLF-44PI M-15T M-04CT MLF-16D M-12T M-01TL2 M-16T M-44PI M-45 MLF-16DE M-48 M-14TB M-25 M-16PT M-11 M-16HT M-03T incl. Flow Diverter M-48 incl. Flow Diverter M-13 MLF-19 M-03 incl. Flow Diverter MLF-11 M-02TL2 MLF-16H M-12 incl. translucent Flow Diverter M-09M M-03 M-47 M-01 M-07 incl. Flow Diverter M-12A M-12 MLF-19GE M-80 M-25T incl. Flow Diverter M-06 MLF-07M M-04C M-09F M-10 M-16 MLF-44 MLF-43 M-43 Doppelpack M-12A Doppelpack M-08T MLF-11K M-14ST MLF-15M MLF-16 MLF-17 M-02T MLF-16DD MLF-60HC M-12 incl.white Diverter M-02 M-09 M-03HDM incl. Flow Diverter M-01T MLF-15 M-15 incl. Flow Diverter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2007-12-18

Official Correspondent

Demian Gambert

US Agent Details

WILLIAM ROETTGER Business: INTERNATIONAL BUSINESS STRATEGIES Email: BILL@ibs-usa.com Phone: (843) 2240553

Related Public Records

Same Entity

IT DR. GAMBERT GMBH
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
K072469 Digiflo, Inc. DIGIFLO CONCENTRATOR ANALYZER 2008-01-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613449. Last updated year: 2026. Please use registration number 9613449 when referencing this establishment in official correspondence.
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