Data / Medical devices / Germany / Ibp Medical GMBH
Ibp Medical GMBH: FDA-registered device maker in HANNOVER Lower Saxony, Germany, 4 510(k) clearances
Ibp Medical GMBH is registered with the FDA (registration 3003884198) in HANNOVER Lower Saxony, Germany. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 2, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003884198
- Address
- Ikarusallee 15, HANNOVER Lower Saxony, Germany, D30179
- Owner or operator
- MESA LABORATORIES, INC. (1720309)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 8, 2019
- Registered through
- 2026
- Brand names listed
- HDC64 SmartHDM-510 Basic Hemodyalysis-Bundle, HDC64 SmartHDM-510 Complete Hemodialysis-Bundle, HDC85 SmartHDM-510 Basic Hemodialysis-Bundle, HDC85 SmartHDM-510 Complete Hemodialysis-Bundle, HDM97, HDU-FL100.2000, Sensor Flow, Secondary Reference Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Meter, Conductivity, Non-Remote | FIZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Solution-Test Standard-Conductivity, Dialysis | FKH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 2, 2020 | K201765 | SmartHDM-510 System | FIZ | Substantially Equivalent | Mesa Laboratories, Inc. | accessdata.fda.gov |
| September 17, 2003 | K032075 | CONDUCTIVITY STANDARD SOLUTION-METERCARE | FKH | Substantially Equivalent | Ibp Instruments GmbH | accessdata.fda.gov |
| May 22, 2002 | K020909 | HDM99 | FIZ | Substantially Equivalent | Ibp Instruments GmbH | accessdata.fda.gov |
| May 22, 2002 | K020908 | HDM97 | FIZ | Substantially Equivalent | Ibp Instruments GmbH | accessdata.fda.gov |
Compare with other makers
Updated September 2, 2020. 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.