Identity
- Trade Name
- Malem FDA UDI
- Generic Name
- Incontinence sensor/alarm FDA UDI
- Device Name
- Malem Audio (MO3) enuresis alarm (sound 2, green) FDA UDI
- Model / Reference
- MO3S2 FDA UDI
- Description
- Malem Audio (MO3) enuresis alarm (sound 2, green) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060049630212 FDA UDI
- FDA Product Code
- KPN FDA UDI
- GMDN Term
- Incontinence sensor/alarm FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.2040 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Incontinence sensor/alarm
Malem by Malem Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Incontinence sensor/alarm.
- SIM sensor MODERATE kit — SIMAVITA (AUST) PTY LTD · Class II
- NewU — THEOS MEDICAL SYSTEMS, INC. · Class II
- SIM assessPLUS sensor pad Light — SIMAVITA (AUST) PTY LTD · Class II
- Smart — THEOS MEDICAL SYSTEMS, INC. · Class II
- SIM sensor LIGHT kit — SIMAVITA (AUST) PTY LTD · Class II
- SIM assess sensor pad Heavy — SIMAVITA (AUST) PTY LTD · Class II
- SIM™ assist — SIMAVITA (AUST) PTY LTD · Class II
- Chummie — THEOS MEDICAL SYSTEMS, INC. · 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
- Malem Medical Limited
Sources (1)
- FDA UDI 848e74af-7f23-4ad6-ba37-596ab1ce0f03 33 fields · synced Jun 1, 2026