Data / Medical devices / Germany / Iem GMBH
Iem GMBH: FDA-registered device maker in Aachen North Rhine-Westphalia, Germany, 3 510(k) clearances
Iem GMBH is registered with the FDA (registration 9617476) in Aachen North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617476
- FEI number
- 1000628323
- Address
- Gewerbepark Brand 42, Aachen North Rhine-Westphalia, Germany, D-52078
- Owner or operator
- IEM GMBH (9035831)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 3, 2012
- Registered through
- 2026
- Brand names listed
- ABPM 7100, HMS CS 6.4, HMS-CS 4.3, HMS-CS 4.7, HMS-CS 5, HMS-CS 6.1.3, HMS-CS 6.3, Mobil-O-Graph PWA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2019 | K173895 | Tel-O-Graph | DXN | Substantially Equivalent | I.E.M. Industrielle Entwicklung and Medizintechnik | accessdata.fda.gov |
| July 19, 2016 | K153557 | ABPM 7100, Hypertension Management Software | DXN | Substantially Equivalent | I.E.M. GmbH | accessdata.fda.gov |
| December 16, 2011 | K110603 | HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) | DXN | Substantially Equivalent | I.E.M. GmbH | accessdata.fda.gov |
Compare with other makers
Updated May 16, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.