gudid
Primary ID: Pro
InnoWave (UDI Pro)
Manufactured by MEDISAFE UK LIMITED
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for InnoWave - Primary ID Pro
Device Regulatory Overview
The InnoWave (Model/Catalog Number: Pro) is a medical device manufactured by MEDISAFE UK LIMITED. This product is indexed under FDA Product Code / Category Classification MEC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Pro
- Product Code / EMDN
- MEC
- Device Name
- The InnoWave Pro Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide ultrasonic cleaning and low-level thermal disinfection of surgical instruments, including complex lumen/cannulated devices, such as robotic surgical instruments.
- Database Sync Date
- 2026-08-09 09:19:10
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of InnoWave?
The registered manufacturer of record for InnoWave is MEDISAFE UK LIMITED.
What is the Primary UDI-DI identifier for InnoWave?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Pro.
What classification code is assigned to this device?
This device is registered under product classification code MEC.
Similar Classification Devices (MEC)
Other Devices by MEDISAFE UK LIMITED
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