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Quality Management System EN ISO 13485:2016 Certificate  
  93/42/EEC Certificate  
  MDR Transition Declaration Declaration  
  MDR Transitional Confirmation Letter Confirmation letter  
  Free Sales Certificate Certificate  
  RoHS3 Declaration  
 
Devices and accessories
Type Name English English English Software
PDD-401 Audiometer CE
Declaration		      

PDD-301/sh

PDD-301/sr

PDD-301/so

Spirometer

Spirométer and Rhinomanometer

Spirometer and Forced Oscillation Technique

 CE
Declaration		      

PDT-111/d

PDT-111/pd

Diffusion capacity test

Whole-body plethysmograph and Diffusion capacity test

 CE
Declaration		      
PRE-201 Ergospirometer
exercise test		 CE
Declaration		      
PCS-3000 Calibration
syringe		 CE
Declaration		      

MPA-30

PMP-30

Anatomically shaped mouthpiece
Mouthpiece with bite-on grip

 CE
Declaration		    
PNC-65 Nose clip CE
Declaration		      
PBF-100 Bacterial and
viral filter		 CE
Declaration		  

Nelson Laboratories
Bacterial filtration efficiency test

Nelson Laboratories
Virus filtration efficiency test
   

HPA - Health Protection Agency
Evaluation of Filtration Efficiencies Against Bacterial and Viral Aerosol Challenges
PWG-33BT

Pulmonary

Waveform
Generator

 CE
Declaration		   User
Manual 		 
HR