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Sign in to claim this brandSaranas, Inc.
US
Last updated May 30, 2026
What Saranas, Inc. makes
Saranas, Inc. manufactures femoral artery/vein access catheters, with a focus on systems designed for real-time monitoring of bleeding complications during procedures. Their primary product, the Early Bird Bleed Monitoring System, is intended to detect and assess hemorrhage risks in vascular interventions.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. Saranas, Inc. is headquartered 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 Saranas, Inc. primarily manufacture?
Saranas, Inc. specializes in femoral artery and vein access catheters. Their focus is on systems like the Early Bird Bleed Monitoring System, which are designed to monitor bleeding complications in real-time during vascular procedures. These devices help clinicians assess hemorrhage risks during interventions.
Where is Saranas, Inc. based, and how does that affect its regulatory standing?
Saranas, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies its products as Class II, indicating they pose moderate risk and require special controls to ensure safety and effectiveness.
Which regulatory databases list Saranas, Inc.’s devices, and why is this important?
Saranas, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) database tracks devices that have undergone premarket notification to demonstrate substantial equivalence to existing products, while the UDI system ensures traceability and transparency in the supply chain. Listing in these databases helps healthcare providers verify device compliance and history.
How are Saranas, Inc.’s devices classified by the FDA, and what does that classification mean?
The FDA classifies Saranas, Inc.’s devices as Class II. This classification means the devices are not low-risk (Class I) but also not high-risk (Class III), requiring additional controls beyond general controls to ensure their safety and performance. Class II devices often involve special labeling, performance standards, or post-market surveillance to mitigate risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- saranas.com
- —
- —
- [email protected]
- Phone
- 18333759273
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 078299103
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Early Bird Bleed Monitoring System | FG001-01 | FDA UDI | Class II | Active |
| Early Bird Bleed Monitoring System | FG001-02 | FDA UDI | Class II | Active |
| Early Bird Bleed Monitoring System | DEN180021 | FDA 510(k) | Class II | Active |
| Saranas Early Bird Bleed Monitoring System | K230273 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Saranas, Inc. has one FDA recall record initiated on 2022-08-10, with the status recorded as both open and classified. The reason cited involves a device design error in a bleed monitoring system, where the device fails to power on and complete self-tests, prompting updated instructions for use to verify proper device function before use.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 10, 2022 | Z-1684-2022 | — | open, classified | Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately. |