Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat MALEM MEDICAL LIMITED makes
Malem Medical Limited produces incontinence sensors and alarm systems designed to detect urinary leakage, as well as vibratory stimulators intended to assist bladder emptying. Their portfolio includes multiple iterations of a wearable device called Malem, which targets male urinary incontinence. These products are primarily focused on non-invasive monitoring and stimulation solutions for bladder control.
The company’s devices fall under FDA Class I and Class II classifications, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
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 Malem Medical Limited manufacture?
Malem Medical Limited specializes in incontinence-related medical devices. Their portfolio includes incontinence sensors and alarm systems, which detect urinary leakage, and vibratory stimulators designed to help users empty their bladder. These devices are primarily non-invasive solutions for managing bladder control issues, with a focus on male urinary incontinence.
Where is Malem Medical Limited based, and how does this affect its devices?
Malem Medical Limited is based in the United States. Since the company operates within the U.S., its devices must comply with FDA regulations, including classification under FDA categories (Class I or Class II) and mandatory listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and regulatory oversight.
Which regulatory registries or databases list Malem Medical Limited’s devices?
Malem Medical Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for tracking, compliance, and transparency in the medical device supply chain, particularly for Class I and Class II devices.
How are Malem Medical Limited’s devices classified by regulatory authorities?
Malem Medical Limited’s devices are classified under FDA categories: some fall under Class I, which typically includes low-risk devices requiring general controls, while others are Class II, which involves special controls to ensure their safety and effectiveness. Classification depends on factors like intended use, risk level, and potential impact on patient health.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 291490076
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Malem | MO4SB | FDA UDI | Class II | Active |
| Malem | MO4S2 | FDA UDI | Class II | Active |
| Malem | MO3S2 | FDA UDI | Class II | Active |
| Malem | MO4S1 | FDA UDI | Class II | Active |
| Malem | MO12 | FDA UDI | Class II | Active |
| Malem | MO4S3 | FDA UDI | Class II | Active |
| Malem | MO25 | FDA UDI | Class II | Active |
| Malem | MO3S1 | FDA UDI | Class II | Active |
| Malem | MO15 | FDA UDI | Class II | Active |
| Malem | MO38T | FDA UDI | Class II | Active |
| Malem | MO3S3 | FDA UDI | Class II | Active |
| Malem | MO7 | FDA UDI | Class II | Active |
| Malem | PC9 | FDA UDI | Class I | Active |
| Malem | MO3V | FDA UDI | Class II | Active |
| Malem | MO4SM | FDA UDI | Class II | Active |
| Malem | MO5B | FDA UDI | Class II | Active |
| Malem | MO6 | FDA UDI | Class II | Active |
| Malem | MO4SC | FDA UDI | Class II | Active |
| Malem | MO38TC | FDA UDI | Class II | Active |
| Malem | MO24 | FDA UDI | Class II | Active |
| Malem | MO5M | FDA UDI | Class II | Active |
| Malem | MO48T | FDA UDI | Class II | Active |
| Malem | PC9S | FDA UDI | Class I | Active |
| Malem | MO17 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.