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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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ZenFlex/ZenFlex One Files/Traverse Files — 77 UDI-DI variants, MDR

MD Atlas
KERR ITALIA SRL

Data from EUDAMED, last updated May 31, 2026

ZenFlex/ZenFlex One Files/Traverse Files

80515118720000015B

77 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: KERR ITALIA SRL

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 80515118720000015B
Device name: ZenFlex/ZenFlex One Files/Traverse Files
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 23, 2026

Manufacturer & authorised representative

Manufacturer

Name: KERR ITALIA SRL
SRN: IT-MF-000007768
Country: Italy
Email: contact.kerritalia@envistaco.com

Variants by status

UDI-DI variants

77 UDI-DI variants

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Applied filters

basicUdiUlid01KME753J1Y0QV74B84HMBDCEN

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

ZenFlex Files08055165031484
ZenFlex Files08055165031552
ZenFlex Files08055165031637
ZenFlex Files08055165031453
ZenFlex Files08055165031903
ZenFlex Files08055165031521
ZenFlex Files08055165031705
ZenFlex Files08055165031477
ZenFlex Files08055165031491
ZenFlex Files08055165031507
ZenFlex Files08055165031439
ZenFlex Files08055165031651
ZenFlex Files08055165031576
ZenFlex Files08055165031620
ZenFlex Files08055165031842
ZenFlex One Files08055165037790
ZenFlex One Files08055165037752
ZenFlex One Files08055165037691
ZenFlex One Files08055165037806
ZenFlex One Files08055165037745
ZenFlex One Files08055165037783
ZenFlex One Files08055165037721
ZenFlex One Files08055165037714
ZenFlex One Files08055165037769
ZenFlex One Files08055165037738

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