.svg)
Frequently Asked Questions
Answers to common questions from distributors, OEM partners, and healthcare buyers.
What products does CareLife USA manufacture and supply?
Products & Capabilities
Do your lancets, syringes, and needles come in different gauges and types?
Products & Capabilities
Can I request product samples or a catalog before placing a bulk order?
Products & Capabilities
What's the difference between your OEM/ODM and private-label services?
OEM & Private Label
Can you produce custom colors, designs, and packaging for our brand?
OEM & Private Label
What's involved in bringing a new or custom device to market with you?
OEM & Private Label
Are your products and facilities FDA registered and certified?
Quality & Compliance
What quality control process do orders go through before shipping?
Quality & Compliance
Do your products meet ISO and CE standards for international markets?
Quality & Compliance
Who can buy from CareLife USA — distributors, clinics, or individuals?
Ordering & Logistics
How do I get a quote or place an order?
Ordering & Logistics
Do you ship internationally, and can I meet your team at trade shows?
Ordering & Logistics
1.
What diabetic care products does Carelife USA offer?
2.
What gauge options are available for lancets?
3.
Are Carelife products available for retail sale?
4.
Do you offer dental supplies?
We ensure patient safety and privacy through strict hygiene standards, trained medical staff, secure digital records, confidentiality policies, and full compliance with healthcare regulations at every stage of care.
Our lancets are available in 28G, 30G, and 33G. Safety lancets (ReadyLance™) are available in 28G × 1.8mm pressure-activated configurations. Please contact us for full gauge and tip length specifications for each product line.
Yes. Our Medt and MedtLite branded products are available for direct consumer purchase at shopmedt.com. B2B distributors and healthcare buyers should contact us directly for wholesale pricing and bulk order arrangements.
Yes. We offer a complete range of dental supplies including irrigation tips, endodontic syringes, and dental needles. These are available under our brand or as private label. Please contact us for detailed specifications.
1.
What does the OEM/ODM process look like?
2.
What is the minimum order quantity (MOQ) for OEM products?
3.
Can Carelife help with regulatory submissions?
4.
Do you offer injection molding for custom medical components?
Our end-to-end OEM/ODM process covers: (1) Conceptual design and requirements gathering, (2) Engineering and prototyping, (3) Reliability testing and regulatory certification, (4) Quality production with ISO 13485 management, and (5) Fulfillment and distribution. We handle all phases or individual stages depending on your needs.
MOQs vary by product type and complexity. Please contact our sales team with your product requirements for a custom quote. We work with distributors, healthcare companies, and retail brands of varying sizes.
Yes. Our dedicated QA/RA team provides regulatory compliance support including FDA 510(k) guidance, ISO certification preparation, and CE marking documentation. We can assist with submissions or help you navigate requirements in your target market.
Yes. We offer full medical-grade injection molding services, including R&D support, engineering design, tooling, and graphics integration. This is available as a standalone service or as part of a full OEM engagement.
1.
What private label customization options are available?
2.
Can I sell Carelife products under my own brand?
3.
How long does private label setup typically take?
We offer full private label customization including custom product colors and designs, packaging design, brand identity integration, and regulatory labeling compliance. Our in-house graphics designer works directly with you to ensure your brand standards are met.
Absolutely. Private labeling is one of our core services. We manufacture the product to your specifications and brand standards, so you go to market with your own label. We handle all manufacturing, QA, and compliance requirements.
Lead times vary based on product complexity, packaging design, and order volume. Simple private label programs on existing product lines can be set up in 6–10 weeks. Custom design projects may require additional time. Contact us for a project-specific timeline.
1.
How do I place a B2B order?
2.
Do you ship internationally?
3.
Is there a QA review before orders ship?
Contact our US-based sales team via the Contact page or emailA dedicated sales representative will work with you to finalize product specifications, pricing, and delivery schedules.
Yes. Carelife USA has been serving international distributors since 2000 with products shipped to 50+ countries. Our fulfillment team manages customs documentation and international logistics. Contact us for export capabilities in your region.
Yes. Every order goes through a dedicated QA/RA staff review before it leaves our facility. This ensures that all products meet the specifications and quality standards agreed upon at the time of purchase.
1.
Are pen needles subject to state-level shipping restrictions?
2.
What FDA requirements apply to your lancet products?
3.
Can you support CE marking for European distribution?
Contact our US-based sales team via the Contact page or emailA dedicated sales representative will work with you to finalize product specifications, pricing, and delivery schedules.
Our lancet products are subject to FDA 510(k) clearance and our manufacturing facilities are FDA establishment-registered. All products meet applicable FDA quality system regulation (QSR/21 CFR Part 820) requirements.
Yes. Our products carry CE marking and our QA team has experience with EU Medical Device Regulation (MDR) requirements. We can provide technical documentation, declarations of conformity, and support notified body engagements for European distribution.
1.
What quality certifications does Carelife USA hold?
2.
Can I receive copies of your quality certificates?
Carelife USA is ISO 13485 certified, CE marked, and FDA registered as both a manufacturer and distributor. Our quality management system follows the ISO 13485 standard for medical devices, ensuring consistent quality from design through delivery.
Yes. Copies of our ISO 13485 certificate, CE declarations of conformity, and FDA establishment registration are available upon request for qualified distributors and business partners. Please contact us directly to request documentation.
