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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Trach-HME with Built-in Speech Valve — 3 UDI-DI variants, MDR

MD Atlas
BenCorpp Srl

Data from EUDAMED, last updated May 30, 2026

Trach-HME with Built-in Speech Valve

805620901svhU6

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: BenCorpp Srl

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 805620901svhU6
Device name: —
Device model: Trach-HME with Built-in Speech Valve
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jun 9, 2023

Manufacturer & authorised representative

Manufacturer

Name: BenCorpp Srl
SRN: IT-MF-000023046
Country: Italy
Email: info@bencorpp.com

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01H2APAFC0ZTEHYW4YWW0K5SWB

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

MEDIFLUX HCH F6 - Trach-HME with Built-in Speech Valve08056209010137
SpeVaX® - Trach-HME with Built-in Speech Valve08056209010120
SpeVaX® - Trach-HME with Built-in Speech Valve08056209010113