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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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  • MD Atlas
  • Plastiflex Group NV

Data from EUDAMED, last updated May 23, 2026

Active non implantable respiratory devices.

54040130000000000000169

5 references

Class IIa
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Manufacturer
Plastiflex Group NV

Device family identification

Device name
Active non implantable respiratory devices.
Basic UDI-DI
54040130000000000000169
Device model
Hybernite : Tube models consist of different lengths, diameter, rib colour, connections within the cuff
Issuing agency
GS1
Version date
Mar 9, 2026

Classification

Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Status
On the market

Manufacturer

Manufacturer

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

Device characteristics

Active device

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • R02010401Cpap circuits

References by status

References

5 references

Export results

Applied filters

  • basicUdiUlid·01KK999ZMEZDAQS8VZNAVV93GX

Format

Summary

31 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
  • Market country
  • Issuing entity
  • 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
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
HHE19018WT0ECBCK HHE19018WT0ECBCK 054040130045461On the market
HRN19018WT0ECWGCHRN19018WT0ECWGC054040130008071On the market
HPE15018KT0030GIHPE15018KT0030GI054040130009821On the market
HPE19018WT0019GIHPE19018WT0019GI054040130035631On the market
HPE15018WT0019GIHPE15018WT0019GI054040130035701On the market