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Sign in to claim this brandWhat SANCTUARY HEALTH SDN. BHD. makes
Sanctuary Health produces latex condoms designed as oral and vaginal barriers for sexual health protection. The portfolio includes multiple variants of the SancDam™ brand, which are intended for use in both vaginal and oral intercourse.
The company’s products are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
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 Sanctuary Health manufacture?
Sanctuary Health specializes in latex-based oral and vaginal sex barrier devices. These products are designed to serve as protective barriers during sexual activity, specifically for vaginal and oral intercourse. The company’s portfolio consists of variants of the SancDam™ brand, which fall under this category.
Where is Sanctuary Health based, and what is its primary focus?
Sanctuary Health is based in the United States. Its primary focus is on developing and manufacturing latex condoms that function as oral and vaginal barriers for sexual health protection. The company’s entire product line centers around these devices.
Which regulatory registries list Sanctuary Health’s devices?
Sanctuary Health’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring traceability and compliance with regulatory requirements.
How are Sanctuary Health’s devices classified under medical device regulations?
Sanctuary Health’s devices are classified as Class II medical devices. This classification is determined based on factors like the intended use, potential risks, and the level of regulatory oversight required to ensure safety and effectiveness. Class II devices typically require special controls beyond general controls to mitigate risks.
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
- 534420066
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SancDam™ | OD001-S62-P284 | FDA UDI | Class II | Active |
| SancDam™ | OD001-S62-P103 | FDA UDI | Class II | Active |
| SancDam™ | OD001-S38-P103 | FDA UDI | Class II | Active |
| SancDam™ | OD001-S56-P103 | FDA UDI | Class II | Active |
| SancDam™ | OD001-S20-P103 | FDA UDI | Class II | Active |
| SancDam™ | OD001-S40-P103 | FDA UDI | Class II | Active |
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