IEM GMBH

FDA Device Registration & Listing · Aachen North Rhine-Westphalia, DE · Registration 9617476

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
9617476
FEI Number
1000628323
Entity Name
IEM GMBH
City/State/Country
Aachen North Rhine-Westphalia, DE
Establishment Address
Gewerbepark Brand 42, Aachen North Rhine-Westphalia D-52078, DE
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
IEM GMBH (Owner Number: 9035831)
Owner / Operator Contact Address
Gewerbepark Brand 42, --, Aachen, DE-NW D-52078, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K153557
PMA Number
N/A

All Registered Proprietary Names

Tel-O-Graph GSM plus Tel-O-Graph BT plus HMS-CS 6.1.3 HMS-CS 5 ABPM 7100 Mobil-O-Graph PWA HMS-CS 6.3 HMS CS 6.4

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-10-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-11-13

Official Correspondent

Melanie Oelbracht

US Agent Details

Maik Endler Business: Sobel Consult Email: localrepresentation@sobelconsult.com Phone: (307) 3950846

Related Public Records

Same Entity

IEM 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
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617476. Last updated year: 2026. Please use registration number 9617476 when referencing this establishment in official correspondence.
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