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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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ONYX B 5.0 — 1 UDI-DI variant, MDD (Tecno-Gaz S.p.A)

MD Atlas
Tecno-Gaz S.p.A

Data from EUDAMED, last updated May 30, 2026

ONYX B 5.0

B-E309AB015ZXY0

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIb

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: Tecno-Gaz S.p.A

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 0425-MED-003503-00
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: ICIM S.P.A. (0425)
Validity: Jan 31, 2024

Identity & classification

Basic UDI-DI: B-E309AB015ZXY0
Device name: ONYX B 5.0
Device model: AB015ZXY
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Version date: Jan 19, 2023

Manufacturer & authorised representative

Manufacturer

Name: Tecno-Gaz S.p.A
SRN: IT-MF-000010075
Country: Italy
Email: aq@tecnogaz.com
Phone: +39 0521 8380

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01GQ4F99X6JHXPBTRPXKRND1EH

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

AB015ZXYE309AB015ZXY0