How to Source Pulse Oximeters Medical Device for Clinical Use
Pulse Oximeters (Finger pulse oximeters, Handheld or portable devices, Wrist-worn oximeters, Range of accuracy (±2% or better)) is classified under Medical Devices. It is therapeutically aligned with reference brands such as Masimo, Nonin, Omron, ChoiceMMed, AccuMed. This guide highlights key sourcing factors buyers should consider when procuring high-quality Pulse Oximeters for formulation, R&D, or bulk manufacturing.
Product Overview:
Pulse oximeters measure blood oxygen saturation (SpO₂) and pulse rate by detecting changes in light absorption through the fingertip or earlobe. They provide quick, non-invasive readings, supporting respiratory health, diagnosing hypoxemia, and monitoring patient status in critical care, home settings, and during respiratory illnesses.
1. Regulatory Compliance & Certifications for Sourcing Pulse Oximeters
- ✔ CE Marking (EU)
- ✔ FDA 510(k) or PMA (US)
- ✔ ISO 13485 certification
2. Technical Suitability & Clinical Use
- ✔ Instruction manuals & datasheets
- ✔ Compatibility with clinical workflows
- ✔ Class I/II/III classification details
3. Supplier Experience & Support
- ✔ Hospital/clinic references
- ✔ On-site device training or support
- ✔ Regulatory audit history
4. Packaging, Storage & Logistics
Ensure sterile packaging and temperature-controlled shipping if required.
- ✔ Shelf life and handling guidelines
- ✔ Customs and import documentation
- ✔ Local distributor or service support
Conclusion
Sourcing Pulse Oximeters as a medical device requires thorough certification review, supplier vetting, and logistics planning. With the right partner, you ensure compliance, safety, and clinical readiness.
Next Step: Get expert assistance in sourcing Pulse Oximeters.
Frequently Asked Questions For Sourcing of Pulse Oximeters
What is the device classification of Pulse Oximeters?
Pulse Oximeters is classified as a Class I/II/III medical device. This determines the level of regulatory control and testing required for approval and use.
What documentation is available with this device?
Each unit is shipped with full documentation, including the CE Certificate (if applicable), FDA clearance number, user manual, technical datasheet, and ISO 13485 certification (if applicable).
What is the typical lead time for Pulse Oximeters?
Typical lead time is 2–4 weeks depending on stock availability, custom configurations, and shipping destination.
Does Pulse Oximeters require special storage conditions?
No special storage required. Store in a clean, dry environment at room temperature unless otherwise specified.
Can Pulse Oximeters be customized for specific clinical needs?
Yes, we offer customization options for bulk orders, including packaging, labeling, or technical features. Contact our team to discuss custom configurations or OEM partnerships.
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