gudid
Primary ID: FLUTE HF WITH PRINTER
FLUTE (UDI FLUTE HF WITH PRINTER)
Manufactured by INVENTIS SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FLUTE - Primary ID FLUTE HF WITH PRINTER
Device Regulatory Overview
The FLUTE (Model/Catalog Number: FLUTE HF WITH PRINTER) is a medical device manufactured by INVENTIS SRL. This product is indexed under FDA Product Code / Category Classification PTO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FLUTE HF WITH PRINTER
- Product Code / EMDN
- PTO
- Device Name
- MIDDLE EAR ANALYZER.Flute HF is a middle ear analyzer, capable of performing: tympanometry and acoustic reflex tests in sequence and automatically, ETF (Eustachian Tube Function) test for both intact and perforated eardrums, and tympanometry at 1000 Hz. Flute HF has, in addition, an integrated thermal printer.
- Database Sync Date
- 2026-08-09 09:04:31
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 FLUTE?
The registered manufacturer of record for FLUTE is INVENTIS SRL.
What is the Primary UDI-DI identifier for FLUTE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FLUTE HF WITH PRINTER.
What classification code is assigned to this device?
This device is registered under product classification code PTO.
Similar Classification Devices (PTO)
Other Devices by INVENTIS SRL
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