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Sign in to claim this brandWellcare International, Inc.
US
Last updated May 23, 2026
What Wellcare International, Inc. makes
Wellcare International, Inc. manufactures nitrile examination and treatment gloves that are non-powdered and non-antimicrobial, designed for medical use. The company also produces thermal vapour lung treatment system catheters for respiratory therapy applications.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Wellcare International, Inc. is based in 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 Wellcare International, Inc. manufacture?
Wellcare International, Inc. specializes in two primary categories of medical devices: nitrile examination and treatment gloves that are non-powdered and non-antimicrobial, which are commonly used in medical examinations and procedures; and thermal vapour lung treatment system catheters, which are designed for respiratory therapy applications to aid in lung treatments.
Where is Wellcare International, Inc. based?
Wellcare International, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
How are Wellcare International, Inc.’s devices classified under U.S. regulations?
Wellcare International, Inc.’s devices are classified as Class I medical devices under FDA regulations. This classification typically applies to low-risk products, such as gloves and certain catheters, where the risk to patients is minimal and general controls are sufficient for ensuring safety and effectiveness.
Are Wellcare International, Inc.’s devices listed in any regulatory databases?
Yes, Wellcare International, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
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
- 106246039
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| WellCare | ENB303 | FDA UDI | Class I | Active |
| WellCare | WBK302 | FDA UDI | Class I | Active |
| WellCare | WBK703 | FDA UDI | Class I | Active |
| WellCare | WNGBK505 | FDA UDI | Class I | Active |
| WellCare | WBK302 | FDA UDI | Class I | Active |
| WellCare | ENB301 | FDA UDI | Class I | Active |
| WellCare | WNGBK502 | FDA UDI | Class I | Active |
| WellCare | WNGBK501 | FDA UDI | Class I | Active |
| WellCare | WNGBK501 | FDA UDI | Class I | Active |
| WellCare | WBK303 | FDA UDI | Class I | Active |
| WellCare | WNGBK503 | FDA UDI | Class I | Active |
| WellCare | WNGBK505 | FDA UDI | Class I | Active |
| WellCare | WBK702 | FDA UDI | Class I | Active |
| WellCare | WNB704 | FDA UDI | Class I | Active |
| WellCare | ENB301 | FDA UDI | Class I | Active |
| WellCare | WBK704 | FDA UDI | Class I | Active |
| WellCare | WNGBK501 | FDA UDI | Class I | Active |
| WellCare | WNGBK504 | FDA UDI | Class I | Active |
| WellCare | ENB302 | FDA UDI | Class I | Active |
| WellCare | WBK301 | FDA UDI | Class I | Active |
| WellCare | WNB705 | FDA UDI | Class I | Active |
| WellCare | WBK303 | FDA UDI | Class I | Active |
| WellCare | WNGBK504 | FDA UDI | Class I | Active |
| WellCare | WNGBK503 | FDA UDI | Class I | Active |
| WellCare | WBK304 | FDA UDI | Class I | Active |
| WellCare | WBK301 | FDA UDI | Class I | Active |
| WellCare | WNGBK503 | FDA UDI | Class I | Active |
| WellCare | ENB302 | FDA UDI | Class I | Active |
| WellCare | ENB301 | FDA UDI | Class I | Active |
| WellCare | WBK304 | FDA UDI | Class I | Active |
| WellCare | WNGBK505 | FDA UDI | Class I | Active |
| WellCare | ENB304 | FDA UDI | Class I | Active |
| WellCare | ENB303 | FDA UDI | Class I | Active |
| WellCare | ENB304 | FDA UDI | Class I | Active |
| WellCare | WNGBK502 | FDA UDI | Class I | Active |
| WellCare | ENB303 | FDA UDI | Class I | Active |
| WellCare | ENB302 | FDA UDI | Class I | Active |
| WellCare | WNB702 | FDA UDI | Class I | Active |
| WellCare | ENB304 | FDA UDI | Class I | Active |
| WellCare | WNB703 | FDA UDI | Class I | Active |
| WellCare | WBK705 | FDA UDI | Class I | Active |
| WellCare | WNGBK504 | FDA UDI | Class I | Active |
| WellCare | WNGBK502 | FDA UDI | Class I | Active |
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