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Pu Yuan

by Pu Yuan Biotech Co., Ltd. Taiwan EUDAMED

Ref Respitronics Elite , Respitronics Elite

EMDN R060101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471988307PYNEB0253 Basic UDI-DIDate29 May 2024RegisteredStatusActive
European UnionCE/MDD Number471988307PYNEB0253 Basic UDI-DIDate29 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Pu Yuan
Respitronics Elite Nebulization Therapy System
Model / Reference
Respitronics Elite
Primary DI / UDI-DI
04719883070395
Basic UDI-DI
471988307PYNEB0253, B-04719883070395
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TW-MF-000026655
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Pu Yuan Biotech Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 12d0c356-7d7a-4834-b04e-bc6745b14dee 61 fields · synced 22 Oct 2026
  • EUDAMED a1ef1810-df9a-49e3-82af-18d23823feb2 61 fields · synced 16 May 2026