gudid
Primary ID: HARP PLUS
HARP (UDI HARP PLUS)
Manufactured by INVENTIS SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HARP - Primary ID HARP PLUS
Device Regulatory Overview
The HARP (Model/Catalog Number: HARP PLUS) is a medical device manufactured by INVENTIS SRL. This product is indexed under FDA Product Code / Category Classification EWO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HARP PLUS
- Product Code / EMDN
- EWO
- Device Name
- AUDIOMETER.Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and certain supra-threshold tests.
- Database Sync Date
- 2026-08-09 09:04:31
Full Regulatory Attributes
🔒 Token Gated
{
"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 HARP?
The registered manufacturer of record for HARP is INVENTIS SRL.
What is the Primary UDI-DI identifier for HARP?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HARP PLUS.
What classification code is assigned to this device?
This device is registered under product classification code EWO.
Similar Classification Devices (EWO)
Other Devices by INVENTIS SRL
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