Data / Medical devices / Netherlands / Meditop BV
Meditop BV: FDA-registered device maker in Montfoort Utrecht, Netherlands, 1 510(k) clearance
Meditop BV is registered with the FDA (registration 3006581122) in Montfoort Utrecht, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 8, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006581122
- Address
- Vlasakker 22, Montfoort Utrecht, Netherlands, 3417XT
- Owner or operator
- MediTop BV (10027208)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 14, 2008
- Registered through
- 2026
- Brand names listed
- Endo-SPONGE Pump, Exsudex, Exsudex disposable canister
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 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 |
|---|---|---|---|---|---|---|
| October 8, 2008 | K082311 | EXSUDEX WOUND DRAINAGE PUMP | OMP | Substantially Equivalent | The Medical Company | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
Updated October 8, 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.