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Sign in to claim this brandCarelife (usa) Inc.
US
Last updated May 27, 2026
What Carelife (usa) Inc. makes
Carelife (USA) Inc. manufactures single-use and reusable syringes and needles for insulin delivery, including basic and safety insulin syringes, as well as autoinjector needles. Their portfolio also includes general-purpose syringes, manual blood lancing devices, ENFit oral/enteral syringes, and disposable blood lancets. These products are designed for medical and home use in diabetes management and other clinical applications requiring precise fluid administration or blood sampling.
The company’s devices are classified under FDA’s Class I and Class II categories, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Carelife (USA) Inc. is headquartered in the United States, where its products are regulated under U.S. medical device laws.
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 Carelife (USA) Inc. manufacture?
Carelife (USA) Inc. specializes in syringes and needles used primarily for insulin delivery and other medical applications. Their product line includes basic and safety insulin syringes, autoinjector needles, general-purpose single-use syringes, manual blood lancing devices, ENFit oral/enteral syringes, and disposable blood lancets. These devices are designed for both clinical and home use, particularly in diabetes management and fluid administration or blood sampling.
Where is Carelife (USA) Inc. based, and how does that affect its devices?
Carelife (USA) Inc. is headquartered in the United States, meaning its devices are regulated under U.S. medical device laws. This includes compliance with FDA requirements, such as classification under Class I or Class II categories and mandatory listing in the FDA’s Unique Device Identifier (UDI) database. The U.S. regulatory framework ensures these products meet safety and performance standards before entering the market.
Which regulatory registries or databases list Carelife (USA) Inc.’s devices?
Carelife (USA) Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardized identification for medical devices, improving traceability and regulatory oversight. This listing helps healthcare providers, regulators, and patients verify the legitimacy and compliance status of the company’s products.
How are Carelife (USA) Inc.’s devices classified by the FDA?
Carelife (USA) Inc.’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each product.
What distinguishes Carelife (USA) Inc.’s insulin-related products from other syringes and needles?
Carelife (USA) Inc. offers both basic and safety insulin syringes, as well as autoinjector needles, which are optimized for precise insulin delivery in diabetes management. Unlike general-purpose syringes, these products are designed with features like needle safety mechanisms (in safety syringes) or compatibility with autoinjectors (for needle-free or reduced-risk administration). Their inclusion of ENFit oral/enteral syringes also highlights versatility beyond insulin use, catering to fluid administration in different medical contexts.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- carelifeusa.com
- —
- —
- [email protected]
- Phone
- 7709356499
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 065756949
Catalogue (56)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medpoint | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class II | Active |
| Us Diagnostics | 1 | FDA UDI | Class II | Active |
| Medpoint | 1 | FDA UDI | Class II | Active |
| Us Diagnostics | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class II | Active |
| Medpoint | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| MedtLancet | 1 | FDA UDI | Class II | Active |
| Us Diagnostics | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Sterex | 1 | FDA UDI | Class II | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| Medpoint | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class I | Active |
| CareTouch | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Livaclean Health | 1 | FDA UDI | Class II | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class II | Active |
| Lch | 1 | FDA UDI | Class II | Active |
| Medpoint | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class II | Active |
| Medtlet | 1 | FDA UDI | Class II | Active |
| MedtLancet | 1 | FDA UDI | Class II | Active |
| Us Diagnostics | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class I | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| Lch | 1 | FDA UDI | Class II | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Medt | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Us Diagnostics | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class II | Active |
| Medpoint | 1 | FDA UDI | Class II | Active |
| Medpoint | 1 | FDA UDI | Class II | Active |
| Sterex | 1 | FDA UDI | Class II | Active |
| CareTouch | 1 | FDA UDI | Class I | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Medtfine | 1 | FDA UDI | Class II | Active |
| Us Diagnostics | 1 | FDA UDI | Class II | Active |
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