Data / Medical devices / Netherlands / IMDS Operations B.V.
IMDS Operations B.V.: FDA-registered device maker in Roden Groningen, Netherlands, 7 510(k) clearances
IMDS Operations B.V. is registered with the FDA (registration 3007740583) in Roden Groningen, Netherlands. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007740583
- Address
- Ceintuurbaan Noord 150, Roden Groningen, Netherlands, 9301 NZ
- Owner or operator
- IMDS Operations B.V. (10029918)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 25, 2016
- Registered through
- 2027
- Brand names listed
- FlowGuide, GuidionShort, Intraclude, Micro Rx, NHanceIT, NHancer Rx, ReCross, ShapeIt and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| August 14, 2026 | K260559 | NHanceIT | DQY | Substantially Equivalent | IMDS Operation B.V. | accessdata.fda.gov |
| April 17, 2025 | K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | DQY | Substantially Equivalent | Imds Operations B.V. | accessdata.fda.gov |
| September 3, 2024 | K241611 | ShapeIT (SI014135) | DQY | Substantially Equivalent | Imds Operations B.V. | accessdata.fda.gov |
| July 13, 2023 | K223728 | Micro Rx | DQY | Substantially Equivalent | Imds Operations B.V. | accessdata.fda.gov |
| July 15, 2021 | K210431 | ReCross | DQY | Substantially Equivalent | Imds Operations B.V. | accessdata.fda.gov |
| August 6, 2020 | K200324 | NHancer Rx | DQY | Substantially Equivalent | Imds Operations B.V. | accessdata.fda.gov |
| January 21, 2020 | K191229 | TrapIt | DQY | Substantially Equivalent | Imds Operations B.V. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2026. 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.