Data / Medical devices / Germany / AMTRION GMBH (formerly Haseke & Kroemker)
AMTRION GMBH (formerly Haseke & Kroemker): FDA-registered device maker in Porta Westfalica North Rhine-Westphalia, Germany, 1 510(k) clearance
AMTRION GMBH (formerly Haseke & Kroemker) is registered with the FDA (registration 3005285078) in Porta Westfalica North Rhine-Westphalia, Germany. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005285078
- Address
- Sandtrift 1, Porta Westfalica North Rhine-Westphalia, Germany, 32457
- Owner or operator
- Amtrion GmbH (10082386)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 21, 2021
- Registered through
- 2026
- Brand names listed
- 28272GM, 28272GS, Chapot® Table System, Claws, SKYDOQ Central Axis, SKYDOQ Monitor Carrier for Spring Arms, SKYDOQ Spring Arm24, SKYDOQ Spring Arm5 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microscope, Surgical | EPT | 1 | Contract manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Manufacturer | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Ac-Powered | FQO | 1 | 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 |
|---|---|---|---|---|---|---|
| July 15, 2008 | K072136 | ULTRASONIC NEBULISER MODEL 2010 | CAF | Substantially Equivalent | Wilfred Kromker GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Stand, Infusion
- All makers of Operating Room Accessories Table Tray
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Table, Operating-Room, Ac-Powered
- All makers of Microscope, Surgical
- All makers of Support, Breathing Tube
Updated July 15, 2008. 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.