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Sign in to claim this brandKESSEL medintim GmbH
US
Last updated May 30, 2026
What KESSEL medintim GmbH makes
Kessel medintim GmbH manufactures mechanical devices for sexual health, including penile vacuum systems for inducing erections, constriction rings for maintaining erections, and vaginal dilators for pelvic floor rehabilitation. Their product line also includes diaphragms and pessaries designed to support contraception and pelvic organ support. These devices are intended for use in clinical and home settings to address erectile dysfunction and pelvic floor conditions.
The company’s devices are classified under FDA regulations as Class I and Class II, with some products subject to 510(k) premarket notifications and others listed under the FDA’s Unique Device Identifier (UDI) system. These products are regulated in the United States, where the manufacturer is based. No additional regulatory bodies or international listings are specified.
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 Kessel medintim GmbH manufacture?
Kessel medintim GmbH specializes in mechanical devices for sexual and pelvic health. Their product line includes penile vacuum devices (like the Active3 Erection System and Manual Erection System) to help induce erections, constriction rings (e.g., 9mm, 12mm, 15mm, 18mm, and 21mm) to maintain erections, and vaginal dilators (such as the Vagiwell Dilator sets and individual dilators) for pelvic floor rehabilitation. They also produce diaphragms and pessaries (e.g., the Caya Contoured Diaphragm) for contraception and pelvic organ support.
Where is Kessel medintim GmbH based, and where are their devices regulated?
Kessel medintim GmbH is based in the United States. Their devices are regulated under FDA guidelines, with classifications ranging from Class I to Class II. Some products require premarket notifications via the FDA’s 510(k) process, while others are listed under the FDA’s Unique Device Identifier (UDI) system. No other regulatory bodies or international listings are mentioned.
Which regulatory registries or databases list Kessel medintim GmbH’s devices?
Kessel medintim GmbH’s devices are listed in the FDA’s 510(k) premarket notification registry for certain products and the FDA’s Unique Device Identifier (UDI) system for others. These registries track devices that require premarket clearance or have been assigned a UDI for traceability and compliance purposes.
How are Kessel medintim GmbH’s devices classified under FDA regulations?
Kessel medintim GmbH’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls or premarket notifications (like the 510(k)) to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- medintim.de
- —
- —
- [email protected]
- Phone
- +496105203720
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 537500365
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Active3 Erection System | AES 3 | FDA UDI | Class II | Active |
| Active Erection System | AES 01 | FDA UDI | Class II | Unknown |
| Vagiwell Dilator 5er Set Premium | Vagiwell P | FDA UDI | Class I | Active |
| Constriction Ring 12mm | RIng 2 | FDA UDI | Class II | Active |
| Vaginal Dilator 3er Set small | Vagiwell S | FDA UDI | Class I | Active |
| Constriction Ring 9mm | RIng 1 | FDA UDI | Class II | Active |
| Caya contoured diaphragm | Caya contoured diaphragm | FDA UDI | Class II | Active |
| Vaginal Dilator 3er Set large | Vagiwell L | FDA UDI | Class I | Active |
| Constriction Ring 15mm | RIng 3 | FDA UDI | Class II | Active |
| Constriction Ring 21mm | RIng 5 | FDA UDI | Class II | Active |
| Constriction Ring 18mm | RIng 4 | FDA UDI | Class II | Active |
| Manual Erection System | MES 01 | FDA UDI | Class II | Active |
| Caya Contoured Diaphragm | K140305 | 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.
- Kessel Medintim Gmbh Morfelden-Walldorf Hesse · DE FEI 3011014178