Identity
- Trade Name
- Men's Liberty EUDAMEDMen's Liberty Acute EUDAMEDFDA UDI
- Generic Name
- Urinary incontinence penis sheath/port, single-use FDA UDI
- Device Name
- Men's Liberty External Catheter EUDAMEDMen's Liberty Acute External Catheter EUDAMEDMen's Liberty Acute (for Omni Medical)) FDA UDI
- Model / Reference
- 23046-90 EUDAMED21026-02 EUDAMEDFDA UDI
- Description
- Men's Liberty Acute (for Omni Medical)) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00653599000090 EUDAMED00653599000106 EUDAMEDFDA UDI
- Basic UDI-DI
- 0653599MLTL EUDAMED0653599MLAEH EUDAMED
- FDA Product Code
- NOA FDA UDI
- EMDN Code
- U070299 EXTERNAL DEVICES FOR THE TREATMENT OF INCONTINENCE - OTHER EUDAMED
- GMDN Term
- Urinary incontinence penis sheath/port, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Market of Registration
- Malta EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Men's Liberty by Argentum Medical, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0653599MLTL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Argentum Medical LLC
- EUDAMED SRN
- US-MF-000003391
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 323a3c89-8b01-47da-b821-35330a8613fe 61 fields · synced Oct 6, 2026
- EUDAMED ef6be180-ae41-41ad-8eca-52b45f2006e2 61 fields · synced May 17, 2026
- FDA UDI 1ceeb9fc-07d5-47ae-9dda-07769daef365 35 fields · synced May 30, 2026