IMDS Operations B.V.
Roden Groningen, NL
IMDS Operations B.V. appears in FDA device records in Roden Groningen, NL. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for IMDS Operations B.V. between 2012 and 2025. The busiest year on record is 2020, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2020 | 2 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | DQY | Substantially Equivalent | |
| K241611 | ShapeIT (SI014135) | DQY | Substantially Equivalent | |
| K223728 | Micro Rx | DQY | Substantially Equivalent | |
| K210431 | ReCross | DQY | Substantially Equivalent | |
| K210110 | Guidion | DQY | Substantially Equivalent | |
| K200324 | NHancer Rx | DQY | Substantially Equivalent | |
| K191229 | TrapIt | DQY | Substantially Equivalent | |
| K121077 | NHANCER | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007740583 | 3007740583 | IMDS Operations B.V. | Ceintuurbaan Noord 150, Roden Groningen 9301 NZ NL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain