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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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Gammex PI Hybrid — 16 UDI-DI variants, MDR

MD Atlas
Ansell Healthcare Europe NV

Data from EUDAMED, last updated May 23, 2026

Gammex PI Hybrid

5414566GEPIHYB340UL

16 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: Ansell Healthcare Europe NV

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 5414566GEPIHYB340UL
Device name: Gammex PI Hybrid
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jan 11, 2023

Manufacturer & authorised representative

Manufacturer

Name: Ansell Healthcare Europe NV
SRN: BE-MF-000000691
Country: Belgium
Email: samantha.marshall@ansell.com
Phone: +447919410683

Variants by status

UDI-DI variants

16 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01GPGF5E6YSEF2A22NWNZ216YY

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

340105080 815414566050805
340105090 915414566050904
340105085 8.515414566050850
340105060 615414566050607
340105065 6.515414566050652
340105070 715414566050706
340105075 7.515414566050751
34010505515414566050553
340063060 615414566630601
340063075 7.515414566630755
340063090 915414566630908
340063080 8.015414566630809
340063065 6.515414566630656
34006305515414566630557
340063070 715414566630700
340063085 8.515414566630854