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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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Export results

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 Files08055165031859
ZenFlex Files08055165031743
ZenFlex Files08055165031699
ZenFlex Files08055165031774
ZenFlex Files08055165031941
ZenFlex Files08055165031767
ZenFlex Files08055165031514
ZenFlex Files08055165031675
ZenFlex Files08055165031606
ZenFlex Files08055165031590
ZenFlex Files08055165031712
ZenFlex Files08055165031569
ZenFlex Files08055165031880
ZenFlex Files08055165031545
ZenFlex Files08055165031866
ZenFlex Files08055165031910
ZenFlex Files08055165031811
ZenFlex Files08055165031460
ZenFlex Files08055165031828
ZenFlex Files08055165031798
ZenFlex Files08055165031873
ZenFlex Files08055165031736
ZenFlex Files08055165031897
ZenFlex Files08055165031729
ZenFlex Files08055165031538

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