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Sign in to claim this brand1. Vivit International Inc
US
Last updated May 23, 2026
What 1. Vivit International Inc makes
The company manufactures single-use personal protective equipment (PPE) for healthcare settings, including surgical and medical face masks, nitrile examination gloves, isolation gowns, professional examination gowns, shoe covers, and surgical caps. These products are designed for clinical and procedural use to maintain sterility and infection control.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Vivit International Inc manufacture?
Vivit International Inc specializes in single-use personal protective equipment (PPE) for healthcare environments. Their portfolio includes surgical and medical face masks, nitrile examination gloves (non-powdered, non-antimicrobial), isolation gowns, professional examination gowns, shoe covers, and surgical caps. These devices are designed to support infection control and sterility during clinical and procedural use.
Where is Vivit International Inc based?
Vivit International Inc is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to FDA regulations and requirements.
Are Vivit International Inc’s devices listed in any regulatory registries?
Yes, Vivit International Inc’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI registry ensures traceability and compliance with FDA requirements for medical devices, helping healthcare providers and regulators identify and track specific products.
How are Vivit International Inc’s devices classified under FDA regulations?
Vivit International Inc’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and compliance requirements for each product.
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
- 815240958
Catalogue (47)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vivit | 31314TM | FDA UDI | Class II | Active |
| Vivit | 230Y | FDA UDI | Class I | Active |
| Vivit | 130Y | FDA UDI | Class I | Active |
| Vivit | 972B | FDA UDI | Class I | Active |
| Vivit | 8440FW | FDA UDI | Class I | Active |
| Vivit | 11215TM | FDA UDI | Class II | Active |
| Vivit | 20522 | FDA UDI | Class I | Active |
| Vivit | 25913 | FDA UDI | Class I | Active |
| Vivit | 331Y | FDA UDI | Class I | Active |
| Vivit | 30215TM | FDA UDI | Class II | Active |
| Vivit | 20521 | FDA UDI | Class I | Active |
| Vivit | 10215TM | FDA UDI | Class II | Active |
| Vivit | 821Y | FDA UDI | Class I | Active |
| Vivit | 313242TMV | FDA UDI | Class II | Active |
| Vivit | 330Y | FDA UDI | Class I | Active |
| Vivit | 830Y | FDA UDI | Class II | Active |
| Vivit | 921P | FDA UDI | Class I | Active |
| Vivit | 10333TM | FDA UDI | Class II | Active |
| Vivit | 10311TM | FDA UDI | Class II | Active |
| Vivit | 131Y | FDA UDI | Class I | Active |
| Vivit | 831Y | FDA UDI | Class II | Active |
| Vivit | 313141EMV | FDA UDI | Class II | Active |
| Vivit | 1131HW | FDA UDI | Class I | Active |
| Vivit | 811Y | FDA UDI | Class I | Active |
| Vivit | 20524 | FDA UDI | Class I | Active |
| Vivit | 8441FW | FDA UDI | Class I | Active |
| Vivit | 30314TM | FDA UDI | Class II | Active |
| Vivit | 31314EM | FDA UDI | Class II | Active |
| Vivit | 820Y | FDA UDI | Class I | Active |
| Vivit | 10111EM | FDA UDI | Class II | Active |
| Vivit | 30114EM | FDA UDI | Class II | Active |
| Vivit | 25914 | FDA UDI | Class I | Active |
| Vivit | 1130HW | FDA UDI | Class I | Active |
| Vivit | 25912 | FDA UDI | Class I | Active |
| Vivit | 13313TM | FDA UDI | Class II | Active |
| Vivit | 25911 | FDA UDI | Class I | Active |
| Vivit | 973B | FDA UDI | Class I | Active |
| Vivit | 920P | FDA UDI | Class I | Active |
| Vivit | 231Y | FDA UDI | Class I | Active |
| Vivit | 313241TMV | FDA UDI | Class II | Active |
| Vivit | 12313TM | FDA UDI | Class II | Active |
| Vivit | 11311TM | FDA UDI | Class II | Active |
| Vivit | 25915 | FDA UDI | Class I | Active |
| Vivit | 20525 | FDA UDI | Class I | Active |
| Vivit | 810Y | FDA UDI | Class I | Active |
| Vivit | 20523 | FDA UDI | Class I | Active |
| Vivit | 10112EM | FDA UDI | Class II | Active |
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