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Sign in to claim this brandRemcoda, LLC
US
Last updated May 23, 2026
What Remcoda, LLC makes
Remcoda, LLC manufactures nitrile and vinyl examination and treatment gloves, both in non-powdered formulations. The gloves are designed for single-use medical procedures and patient care, ensuring barrier protection during clinical examinations and treatments.
These products are classified as Class I medical devices under U.S. regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for these categories of personal protective equipment.
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 Remcoda, LLC manufacture?
Remcoda, LLC specializes in nitrile and vinyl examination and treatment gloves. These gloves are formulated as non-powdered and, in the case of nitrile, non-antimicrobial. They are designed for single-use applications in medical settings, providing barrier protection during clinical examinations and treatments.
Where is Remcoda, LLC based?
Remcoda, LLC is based in the United States. The company operates from there while adhering to U.S. regulatory standards for the devices it manufactures.
Which regulatory registries list Remcoda, LLC’s devices?
Remcoda, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability.
How are Remcoda, LLC’s gloves classified under U.S. regulations?
Remcoda, LLC’s nitrile and vinyl examination/treatment gloves fall under Class I medical device classification in the U.S. This classification applies to devices posing minimal risk, where general controls (like good manufacturing practices) are sufficient for safety and effectiveness.
Why are Remcoda, LLC’s gloves listed in the FDA’s UDI database?
The FDA’s UDI database includes devices that have been assigned a Unique Device Identifier to improve tracking, reduce medical errors, and enhance transparency in the healthcare system. Since Remcoda’s gloves are authorized for use in the U.S., they are included to ensure proper identification and regulatory oversight.
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
- 117130169
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bluzen | MNIT104-S | FDA UDI | Class I | Active |
| Bluzen | MVIN101-M | FDA UDI | Class I | Active |
| Bluzen | MNIT103-M | FDA UDI | Class I | Active |
| Bluzen | NIT103-M | FDA UDI | Class I | Active |
| Bluzen | NIT102-L | FDA UDI | Class I | Active |
| Bluzen | NIT102-M | FDA UDI | Class I | Active |
| Bluzen | MNIT104-M | FDA UDI | Class I | Active |
| Bluzen | NIT102-S | FDA UDI | Class I | Active |
| Bluzen | MNIT103-XXL | FDA UDI | Class I | Active |
| Bluzen | MNIT104-L | FDA UDI | Class I | Active |
| Bluzen | MNIT104-XXL | FDA UDI | Class I | Active |
| Bluzen | NIT104-M | FDA UDI | Class I | Active |
| Bluzen | NIT103-L | FDA UDI | Class I | Active |
| Bluzen | NIT101-XL | FDA UDI | Class I | Active |
| Bluzen | NIT101-S | FDA UDI | Class I | Active |
| Bluzen | MNIT104-XL | FDA UDI | Class I | Active |
| Bluzen | NIT104-S | FDA UDI | Class I | Active |
| Bluzen | MNIT103-S | FDA UDI | Class I | Active |
| Bluzen | MVIN101-S | FDA UDI | Class I | Active |
| Bluzen | MVIN101-XXL | FDA UDI | Class I | Active |
| Bluzen | NIT101-M | FDA UDI | Class I | Active |
| Bluzen | NIT104-XL | FDA UDI | Class I | Active |
| Bluzen | NIT102-XL | FDA UDI | Class I | Active |
| Bluzen | NIT104-L | FDA UDI | Class I | Active |
| Bluzen | MNIT103-L | FDA UDI | Class I | Active |
| Bluzen | MVIN101-XL | FDA UDI | Class I | Active |
| Bluzen | MNIT103-XL | FDA UDI | Class I | Active |
| Bluzen | MVIN101-XS | FDA UDI | Class I | Active |
| Bluzen | NIT101-L | FDA UDI | Class I | Active |
| Bluzen | NIT103-S | FDA UDI | Class I | Active |
| Bluzen | MVIN101-L | FDA UDI | Class I | Active |
| Bluzen | NIT103-XL | FDA UDI | Class I | Active |
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