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Sign in to claim this brandGynetics Medical Products NV
US
Last updated May 27, 2026
What Gynetics Medical Products NV makes
Gynetics Medical Products NV manufactures single-use devices for assisted reproductive procedures, including intrauterine insemination cannulas, oocyte aspiration needles (both single and double lumen), and endometrial biopsy kits. Their portfolio also covers embryo transfer catheters, designed for precision during fertility treatments such as IVF and IUI.
The company’s devices are classified as Class II under regulatory frameworks, with submissions listed in FDA 510(k) and FDA UDI registries. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gynetics Medical Products NV manufacture?
Gynetics Medical Products NV specializes in single-use devices primarily used in assisted reproductive procedures. Their portfolio includes intrauterine insemination cannulas, oocyte aspiration needles (both single and double lumen), endometrial biopsy kits, and embryo transfer catheters. These devices are designed for precision during fertility treatments like IVF (in vitro fertilization) and IUI (intrauterine insemination).
Where is Gynetics Medical Products NV based?
Gynetics Medical Products NV is based in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and compliance framework, particularly for devices marketed in the US.
How are the devices manufactured by Gynetics Medical Products NV classified under regulatory standards?
The devices produced by Gynetics Medical Products NV fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness. Class II devices often require pre-market notifications (such as FDA 510(k) submissions) to demonstrate substantial equivalence to legally marketed devices.
Which regulatory registries list devices from Gynetics Medical Products NV?
Devices from Gynetics Medical Products NV are listed in the FDA 510(k) registry and the FDA Unique Device Identifier (UDI) system. The 510(k) submission process is used to demonstrate that a new device is at least as safe and effective as a legally marketed predicate device, while the UDI system ensures traceability and identification of medical devices in the market.
Why are Gynetics Medical Products NV’s devices relevant to assisted reproduction registries?
Gynetics Medical Products NV’s devices are directly relevant to assisted reproduction registries because they are designed for critical steps in fertility treatments, such as embryo transfer, oocyte aspiration, and intrauterine insemination. Since these procedures are closely monitored for safety and efficacy, regulatory registries track devices like theirs to ensure compliance with standards and maintain transparency in clinical outcomes. Their Class II classification also means these devices undergo additional scrutiny to mitigate risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- gynetics.com
- —
- —
- [email protected]
- Phone
- +3211645872
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 283088573
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Intrauterine insemination cannula | #4502 B Seminor Flexible | FDA UDI | Class II | Active |
| Follicle Aspiration needle - single lumen flush | #4551 FAS FD | FDA UDI | Class II | Active |
| Follicle Aspiration needle - single lumen | #4551 FAS XD-BCB2 | FDA UDI | Class II | Active |
| Intrauterine insemination cannula | #4502 A Seminor Rigid | FDA UDI | Class II | Active |
| Intrauterine insemination cannula | #4220 Plus | FDA UDI | Class II | Active |
| Gynosampler | #9164 | FDA UDI | Class II | Active |
| Embryo transfer catheter | #4219 Emtrac Delphin | FDA UDI | Class II | Active |
| Intrauterine insemination cannula | #4220 IUI Memo | FDA UDI | Class II | Active |
| Follicle Aspiration needle - double lumen flush | #4551 FAS C2 | FDA UDI | Class II | Active |
| Intrauterine insemination cannula | #4220 IUI | FDA UDI | Class II | Active |
| Intrauterine insemination cannula | #4225 Smooze Medium | FDA UDI | Class II | Active |
| Soft embryo transfer catheter | #2000 Semtrac Set 4.2 | FDA UDI | Class II | Active |
| Soft embryo transfer catheter | #2000 Semtrac W-240 | FDA UDI | Class II | Active |
| Soft embryo transfer catheter | #2000 Semtrac W-180 | FDA UDI | Class II | Active |
| Embryo transfer catheter | #4000 The Tulip Memo | FDA UDI | Class II | Active |
| Intrauterine insemination cannula | #4225 Smooze | FDA UDI | Class II | Active |
| Embryo transfer catheter | #4000 The Tulip | FDA UDI | Class II | Active |
| Soft embryo transfer catheter | #2000 Semtrac Set 5 | FDA UDI | Class II | Active |
| Echosampler | #5164 Echosampler | FDA UDI | Class II | Active |
| Intrauterine insemination cannula | #4225 Smooze Long | FDA UDI | Class II | Active |
| Embryo transfer catheter | #4219 Emtrac Set | FDA UDI | Class II | Active |
| Echosampler | K041237 | FDA 510(k) | Class II | Active |
| Emtrac; Delphin; Semtrac 2000 Set | K013536 | FDA 510(k) | Class II | Active |
| Fas Set #4551 | K013497 | FDA 510(k) | Class II | Active |
| Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 A, B | K013501 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Gynetics Medical Products Nv Lommel Limburg · BE FEI 3003474731