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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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Orbis Hypodest 2,5 %, Sodium… — 1 UDI-DI variant, MDR

MD Atlas
DNTL Nordic ApS

Data from EUDAMED, last updated May 31, 2026

Orbis Hypodest 2,5 %, Sodium hypochlorite 2,5 %, 1000 ml

571473412012B3

1 UDI-DI variant

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: DNTL Nordic ApS

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 571473412012B3
Device name: Orbis Hypodest 2,5 %, Sodium hypochlorite 2,5 %, 1000 ml
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jan 12, 2025

Manufacturer & authorised representative

Manufacturer

Name: DNTL Nordic ApS
SRN: DK-MF-000013594
Country: Denmark
Email: dntlnordic@dntlnordic.dk
Phone: +45 61699218

Variants by status

UDI-DI variants

1 UDI-DI variant

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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

Orbis Hypodest 2,5 %, Sodium hypochlorite 2,5 %, 1000 ml05714734120129