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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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GastroFlex™N — 2 UDI-DI variants, MDR (MAUNA KEA TECHNOLOGIES)

MD Atlas
MAUNA KEA TECHNOLOGIES

Data from EUDAMED, last updated May 19, 2026

GastroFlex™N

376018791NCM2DX

2 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: MAUNA KEA TECHNOLOGIES

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 376018791NCM2DX
Device name: GastroFlex™N
Device model: GastroFlex™N
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Feb 11, 2026

Manufacturer & authorised representative

Manufacturer

Name: MAUNA KEA TECHNOLOGIES
SRN: FR-MF-000000835
Country: France
Email: ra@maunakeatech.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KH6EE1BEZC5MBME14ZVC1937

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

FP-1003103760187912035
FP-1003003760187912028