Identity
- Trade Name
- Active3 Erection System FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- Vaccum Erection Device for treatment of erectily dysfunction FDA UDI
- Model / Reference
- AES 3 FDA UDI
- Description
- Vaccum Erection Device for treatment of erectily dysfunction FDA UDI
Identifiers
- Catalog Number
- AES 3 FDA UDI
- Primary DI / UDI-DI
- 04013273001915 FDA UDI
- FDA Product Code
- LKY FDA UDI
- GMDN Term
- Penile vacuum device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Penile vacuum device
Active3 Erection System by KESSEL medintim GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Penile vacuum device.
- Timm Medical — Pos-T-Vac LLC
- Encore — ENCORE, INC. · Class II
- Loading Cone — AUGUSTA MEDICAL SYSTEMS, L.L.C. · Class II
- Encore — ENCORE, INC. · Class II
- Elite Custom Plus — AUGUSTA MEDICAL SYSTEMS, L.L.C. · Class II
- Encore — ENCORE, INC. · Class II
- PERFORMANCE — Blush Novelties · Class II
- MAPTAG — MAPTAG (QINGDAO) MEDICAL TECHNOLOGY CO., LTD. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KESSEL medintim GmbH
Sources (1)
- FDA UDI ba0587af-4d85-41d3-9527-40bf632fda02 36 fields · synced Jun 1, 2026