FDA Registration
Active
🇩🇪 Germany
KESSEL MEDINTIM GMBH
Reg #: 3011014178
·
FEI: 3011014178
·
Expires 2026
Products
4
Proprietary Names
13
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- KESSEL MEDINTIM GMBH
- Registration Number
- 3011014178
- FEI Number
- 3011014178
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kelsterbacher Str. 28
- City
- Morfelden-Walldorf Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K140305
Owner / Operator
- Firm Name
- Kessel medintim GmbH
- Operator Number
- 10048803
- Address
- Kelsterbacher Str. 28
- City
- Morfelden-Walldorf
- State
- Hesse
- Postal Code
- 64546
- Country
- DE
- Correspondent
- Martin Kessel
US Agent
- Business Name
- HPSRX ENTERPRISES, INC.
- Contact Name
- Bob Patane
- Address
- 1640 ROANOKE BLVD
- City
- Salem
- State
- VA
- ZIP
- 24153
- Country
- US
- [email protected]
- Phone
- 540 3759380
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2019-11-27 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2021-02-08 |
| Diaphragm, Contraceptive (And Accessories) | HDW | Class 2 | Obstetrics/Gynecology | No | 2015-03-03 |
| Device, External Penile Rigidity | LKY | Class 2 | Gastroenterology, Urology | No | 2015-10-19 |
Proprietary Names
Vagiwell Dilators Set Large
Vagiwell Dilators Set Small
Vagiwell Dilators Set Premium
Prosecca Band
Caya contoured diaphragm
Rehabi Penile Vacuum Trainer
Manual Erection System
Active3 Erection System
Constriction ring 9mm
Constriction ring 12 mm
Constriction ring 18mm
Constriction ring 21mm
Constriction ring 15mm
Establishment Types
Manufacture Medical Device