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Sign in to claim this brandSIMAVITA (AUST) PTY LTD
US
Last updated May 24, 2026
What SIMAVITA (AUST) PTY LTD makes
The company manufactures incontinence monitoring devices, including sensor pads, alarm systems, and accompanying tablet accessories designed to detect and alert users to moderate or light incontinence events. Products range from standalone sensor pads to comprehensive kits that integrate with tablet-based platforms for assessment and management.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable medical device regulations for incontinence monitoring solutions.
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 Simavita (Aust) Pty Ltd manufacture?
Simavita (Aust) Pty Ltd specializes in incontinence monitoring devices. Their products include sensor pads, alarm systems, and tablet accessories designed to detect and alert users to incontinence events. Examples include standalone sensor pads like the SIM sensor Light or Moderate, as well as comprehensive kits like the SIM™ kit or SIM assessPLUS sensor pad kits, which integrate with tablet-based platforms for assessment and management.
Where is Simavita (Aust) Pty Ltd based?
The company is based in the United States. This location ensures compliance with U.S. medical device regulations, which govern the development, manufacturing, and distribution of their incontinence monitoring solutions.
Which regulatory registries list Simavita’s devices?
Simavita’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II incontinence monitoring products, ensuring transparency and traceability in the medical device supply chain.
How are Simavita’s devices classified under regulatory frameworks?
Simavita’s incontinence monitoring devices fall under Class II classification. This classification is determined based on their intended use, risk level, and regulatory requirements, which typically require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 757459958
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SIM sensor Moderate | 6009 | FDA UDI | Class II | Active |
| SIM™ assist | 7001 | FDA UDI | Class II | Active |
| SIM assess sensor pad kit - MODERATE | 6022 | FDA UDI | Class II | Active |
| SIM™ tablet accessories | 6035 | FDA UDI | Class II | Active |
| SIM sensor Light | 6008 | FDA UDI | Class II | Active |
| SIM assessPLUS sensor pad kit - MODERATE | 6028 | FDA UDI | Class II | Active |
| SIM™ kit | 6033 | FDA UDI | Class II | Active |
| SIM assess sensor pad Light | 6024 | FDA UDI | Class II | Active |
| SIM™ tablet accessories | 6035 | FDA UDI | Class II | Active |
| SIM assessPLUS sensor pad kit - LIGHT | 6027 | FDA UDI | Class II | Active |
| SIM sensor LIGHT kit | 6015 | FDA UDI | Class II | Active |
| SIM™ kit | 6033 | FDA UDI | Class II | Active |
| SIM assess sensor pad kit - LIGHT | 6021 | FDA UDI | Class II | Active |
| SIM pants Regular | 1303 | FDA UDI | Class II | Active |
| SIM™ tablet accessories | 6035 | FDA UDI | Class II | Active |
| SIM sensor MODERATE kit | 6016 | FDA UDI | Class II | Active |
| SIM assess sensor pad kit - HEAVY | 6023 | FDA UDI | Class II | Active |
| SIM sensor HEAVY kit | 6017 | FDA UDI | Class II | Active |
| SIM tablet | 6034 | FDA UDI | Class II | Active |
| SIM™ dock | 6020 | FDA UDI | Class II | Active |
| SIM assess sensor pad Heavy | 6026 | FDA UDI | Class II | Active |
| SIM™ tablet accessories | 6035 | FDA UDI | Class II | Active |
| SIM pod kit | 6010 | FDA UDI | Class II | Active |
| SIM assessPLUS sensor pad Moderate | 6031 | FDA UDI | Class II | Active |
| SIM pod kit | 6010 | FDA UDI | Class II | Active |
| SIM pants XL | 1305 | FDA UDI | Class II | Active |
| SIM pants XXL | 1307 | FDA UDI | Class II | Active |
| SIM pod kit | 6010 | FDA UDI | Class II | Active |
| SIM assess sensor pad Moderate | 6025 | FDA UDI | Class II | Active |
| SIM™ kit | 6033 | FDA UDI | Class II | Active |
| SIM™ pod | 6019 | FDA UDI | Class II | Active |
| SIM assessPLUS sensor pad Heavy | 6032 | FDA UDI | Class II | Active |
| SIM assessPLUS sensor pad Light | 6030 | FDA UDI | Class II | Active |
| SIM pod kit | 6010 | FDA UDI | Class II | Active |
| SIM assessPLUS sensor pad kit - HEAVY | 6029 | FDA UDI | Class II | Active |
| SIM sensor Heavy | 6017 | FDA UDI | Class II | Active |
| SIM™ kit | 6033 | FDA UDI | Class II | Active |
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