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Sign in to claim this brandWhat CORMAN SPA makes
Corman Spa manufactures unscented menstrual tampons designed for internal use during menstruation. The products are distributed under various brand names, including Azalea Tampons and 365 by Whole Foods Market, focusing on hygiene and comfort for consumers.
These devices are classified as Class II under regulatory standards and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for tampons.
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 Corman Spa manufacture?
Corman Spa specializes in manufacturing unscented menstrual tampons intended for internal use during menstruation. These products are designed to provide hygiene and comfort for consumers and are distributed under multiple brand names, such as Azalea Tampons and 365 by Whole Foods Market. The focus is on a single category of Class II devices, ensuring compliance with regulatory standards for menstrual hygiene products.
Where is Corman Spa based, and how does that affect its operations?
Corman Spa is based in the United States. Being headquartered there means the company operates under U.S. medical device regulations, including those governing tampons. This includes adherence to manufacturing, labeling, and distribution requirements specific to the FDA, ensuring its products meet domestic and international standards when sold globally.
Which regulatory registries list Corman Spa’s devices?
Corman Spa’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and consumers to verify the identity and compliance status of the tampons under brand names like Azalea Tampons or 365 by Whole Foods Market. The UDI system is a key tool for monitoring Class II devices like these.
How are Corman Spa’s menstrual tampons classified under regulatory standards?
Corman Spa’s menstrual tampons are classified as Class II devices. This classification is based on their intended use and associated risks, where they require special controls beyond general controls to ensure safety and effectiveness. Class II devices like these undergo rigorous evaluation to mitigate risks such as infection or irritation, ensuring they meet regulatory requirements before distribution.
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
- 428129167
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| THE HONEST COMPANY Inc | Applicator tampons SUPER | FDA UDI | Class II | Active |
| Earth Fare | Applicator Regular | FDA UDI | Class II | Active |
| Azalea Tampons | Applicator Biobased SUPER | FDA UDI | Class II | Active |
| Azalea Tampons | No Applicator Regular | FDA UDI | Class II | Active |
| 365 by Whole Foods Market | 0001317 | FDA UDI | Class II | Active |
| THE HONEST COMPANY Inc | Applicator tampons SUPER PLUS | FDA UDI | Class II | Active |
| Azalea Tampons | No Applicator Super | FDA UDI | Class II | Active |
| Brandless | Applicator Regular | FDA UDI | Class II | Active |
| Organyc | No Applicator Regular | FDA UDI | Class II | Active |
| Earth Fare | No Applicator Regular | FDA UDI | Class II | Active |
| Organyc | Applicator tampons SUPER PLUS | FDA UDI | Class II | Active |
| THE HONEST COMPANY Inc | Applicator tampons SUPER PLUS | FDA UDI | Class II | Active |
| Azalea Tampons | Applicator Biobased MULTIPACK | FDA UDI | Class II | Active |
| Organyc | No Applicator Super Plus | FDA UDI | Class II | Active |
| Brandless | Applicator Super | FDA UDI | Class II | Active |
| Earth Fare | No Applicator Super | FDA UDI | Class II | Active |
| Azalea Tampons | Applicator Regular | FDA UDI | Class II | Active |
| Organyc | Applicator Super | FDA UDI | Class II | Active |
| Organyc | Applicator tampons REGULAR | FDA UDI | Class II | Active |
| Azalea Tampons | Applicator Biobased REGULAR | FDA UDI | Class II | Active |
| 365 by Whole Foods Market | 0001320 | FDA UDI | Class II | Active |
| 365 by Whole Foods Market | 0001321 | FDA UDI | Class II | Active |
| Organyc | Applicator Super Plus | FDA UDI | Class II | Active |
| THE HONEST COMPANY Inc | Applicator tampons REGULAR | FDA UDI | Class II | Active |
| 365 by Whole Foods Market | 0001319 | FDA UDI | Class II | Active |
| Organyc | Applicator Regular | FDA UDI | Class II | Active |
| Organyc | No Applicator Super | FDA UDI | Class II | Active |
| Azalea Tampons | Applicator Super | FDA UDI | Class II | Active |
| Organyc | Applicator tampons SUPER | FDA UDI | Class II | Active |
| Earth Fare | Applicator Super | FDA UDI | Class II | Active |
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