Shah Eye Care has reached an important milestone with its Acuflow Coaxial I/A Handpiece, which is now MDR Certified. This certification marks another step in Shah Eye Care’s commitment to developing reliable ophthalmic surgical devices that meet the requirements of the European Medical Device Regulation.
Building on the trusted legacy of Acucut, Shah Eye Care introduces Acuflow as a high-precision, single-use medical device designed for ophthalmic surgical procedures. The MDR Certified Coaxial I/A Handpiece connects to irrigation and aspiration tubing systems and works with phacoemulsification and vitrectomy devices.
Designed for Controlled Irrigation and Aspiration
Effective irrigation and aspiration are important during ophthalmic surgery. Acuflow Coaxial I/A Handpieces are designed with features that support efficient fluid delivery and aspiration.
The irrigation handpiece has a larger 1.00 × 1.20 mm diameter with two holes, while the aspiration handpiece includes a 0.35 mm diameter hole for effective fluid suction. The thin-wall construction is designed to support maximum flow efficiency.
Key Features of the Acuflow Coaxial I/A Handpiece
The Acuflow range combines practical design features with a focus on surgical handling and fluid management:
- MDR Certified for the applicable medical device requirements
- Matt-finished handpiece tip designed for precision polishing
- High-quality stainless-steel construction
- Transparent handles for better flow visibility
- Ergonomic handle design for comfortable handling and control
- Efficient irrigation through a 1.00 × 1.20 mm irrigation design with two holes
- 0.35 mm aspiration hole for effective fluid suction
- Thin-wall construction for improved flow efficiency
- Standard male and female luer connectors for secure attachment
- ETO sterilized and supplied as a single-use medical device
Multiple Gauge and Angulation Options
Acuflow Coaxial I/A Handpieces are available in different gauge and angulation configurations to suit different surgical requirements. The product range includes 20G, 21G and 23G options, with straight, 45° and 65° configurations depending on the model.
This range gives ophthalmic professionals options when selecting a coaxial I/A handpiece according to their procedural preferences.
Why MDR Certification Matters
The MDR framework establishes regulatory requirements for medical devices marketed in the European Union. For Shah Eye Care, achieving MDR certification for Acuflow Coaxial I/A Handpieces represents an important step toward making its ophthalmic surgical products available in more markets while following applicable regulatory requirements.
With this milestone, Shah Eye Care continues to expand its portfolio of ophthalmic surgical devices while maintaining attention to product design, usability, and manufacturing requirements.
Acuflow: Built for Ophthalmic Surgical Applications
From its transparent ergonomic handle to its matt-finished stainless-steel tip and optimized irrigation and aspiration design, the Acuflow Coaxial I/A Handpiece is developed with the practical requirements of ophthalmic surgery in mind.
The MDR Certified Coaxial I/A Handpiece from Shah Eye Care brings together controlled fluid management, ergonomic handling, multiple configuration options, and single-use convenience in one surgical device.
Looking Ahead
The MDR certification of Acuflow Coaxial I/A Handpieces is an important addition to Shah Eye Care’s ophthalmic product portfolio. As the company continues to serve ophthalmic professionals and markets worldwide, Acuflow represents another step toward providing dependable solutions for modern eye surgery.
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