Data / Medical devices / Netherlands / Comecer Netherlands b.v.
Comecer Netherlands b.v.: FDA-registered device maker in Joure Fryslan, Netherlands, 1 510(k) clearance
Comecer Netherlands b.v. is registered with the FDA (registration 3009694288) in Joure Fryslan, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 18, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009694288
- Address
- Madam Curieweg 1, Joure Fryslan, Netherlands, nl/8501AC
- Owner or operator
- Comecer Netherlands (10041109)
- Roles
- Manufacturer
- First device listed
- September 22, 2014
- Registered through
- 2026
- Brand names listed
- IBC-dose calibrator, IBC-dose calibrator XR, VDC-606, VDC-606XR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Dose, Radionuclide | KPT | 2 | 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 18, 2014 | K142325 | Veenstra Instruments VDC-506 Dose Calibrator | KPT | Substantially Equivalent | Comecer Netherlands B.V. | accessdata.fda.gov |
Updated September 18, 2014. 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.