Gynetics Medical Products NV
Lommel Limburg, BE
GYNETICS MEDICAL PRODUCTS NV appears in FDA device records in Lommel Limburg, BE. FDA records list 4 510(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 4 510(k) clearances for Gynetics Medical Products NV between 2001 and 2004. The busiest year on record is 2001, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041237 | ECHOSAMPLER | HFF | Substantially Equivalent | |
| K013536 | EMTRAC; DELPHIN; SEMTRAC 2000 SET | MQF | Substantially Equivalent | |
| K013501 | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B | MQF | Substantially Equivalent | |
| K013497 | FAS SET #4551 | MQE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043478 | 3003474731 | GYNETICS MEDICAL PRODUCTS NV | Rembert Dodoensstraat 51, Lommel Limburg 3920 BE | 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