Data / Medical devices / Belgium / Gynetics Medical Products NV
Gynetics Medical Products NV: FDA-registered device maker in Lommel Limburg, Belgium, 5 510(k) clearances
Gynetics Medical Products NV is registered with the FDA (registration 8043478) in Lommel Limburg, Belgium. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 8, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043478
- FEI number
- 3003474731
- Address
- Rembert Dodoensstraat 51, Lommel Limburg, Belgium, 3920
- Owner or operator
- Gynetics Medical Products (9001946)
- Roles
- Manufacturer
- First device listed
- November 21, 2007
- Registered through
- 2026
- Brand names listed
- Delphin, Echosampler, Emtrac, FAS, IUI, Probet, Seminor, Semtrac and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspirator, Endometrial | HFF | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Assisted Reproduction | MQF | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Assisted Reproduction | MQE | 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 8, 2004 | K041237 | ECHOSAMPLER | HFF | Substantially Equivalent | Gynetics Medical Products NV | accessdata.fda.gov |
| November 30, 2001 | K013536 | EMTRAC; DELPHIN; SEMTRAC 2000 SET | MQF | Substantially Equivalent | Gynetics Medical Products NV | accessdata.fda.gov |
| November 30, 2001 | K013501 | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B | MQF | Substantially Equivalent | Gynetics Medical Products NV | accessdata.fda.gov |
| November 9, 2001 | K013497 | FAS SET #4551 | MQE | Substantially Equivalent | Gynetics Medical Products NV | accessdata.fda.gov |
| April 5, 1991 | K903002 | PROBET (TM) | HFF | Substantially Equivalent | Gynopharma, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Assisted Reproduction
- All makers of Aspirator, Endometrial
- All makers of Catheter, Assisted Reproduction
Updated September 8, 2004. 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.