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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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Hybernite RT — 20 UDI-DI variants, MDR (Plastiflex Group NV)

MD Atlas
Plastiflex Group NV

Data from EUDAMED, last updated May 23, 2026

Hybernite RT

5404013000000000000026B

20 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: Plastiflex Group NV

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 5404013000000000000026B
Device name: Hybernite RT
Device model: The Hybernite RT breathing tubes are combined in breathing sets in a single limb version (only inspiratory tube) or a dual limb (inspiratory and expiratory tube) version. Products are available in 3 diameters and in different packaging combinations
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Aug 18, 2023

Manufacturer & authorised representative

Manufacturer

Name: Plastiflex Group NV
SRN: BE-MF-000008049
Country: Belgium
Email: info@plastiflex.com
Phone: +32 11 43 58 00

Variants by status

UDI-DI variants

20 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01H840SK1HH98EJH1DRSAC9EMW

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

HPN12020BT4047BB05404013001033
HEN19038BT1SSWGK05404013003600
HFN19022BT1SSWGK05404013003631
HFN19022BT1STWGL05404013003730
HPN12016WT0FQWBB05404013000227
HPN12016BT1FTWBB05404013000210
HPN12016BT1ETWBC05404013002757
HPN12020BT1FQWBB05404013000234
HPN12020BT1EPWBB05404013002771
HPN15017BT1FTWBC05404013003686
HPN15017WT0FRWBB05404013000258
HPN15017BT1FTWBB05404013000241
HPN19016BT1FTWBC05404013003679
HPN19016WT0FSWBB05404013000272
HPN19016BT1FTWBB05404013000265
HEN15040BT1SSWGK05404013003594
HFN15023BT1SSWGK05404013003624
HEN12041BT1PRWGK05404013003587
HFN12025BT1PRWGK05404013003617
HPN12016WT0EPWBB05404013004928