Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Hans Rudolph Inc

Address:

8325 Cole Parkway

Shawnee

Kansas KS 66227,

United States

Authorised Representative/ UK Responsible Person
Name: Responsible Person Ltd
Address:

Summit House 4-5 Mitchell Street

Edinburgh

EH6 7BD

Scotland United Kingdom

Code/Term Type

Exhaled-gas sample collector non-electronic Exhaled-gas sample collector non-electronic Class IIa

Pneumotachograph Pneumotachograph Class IIa

Non-rebreathing valve reusable Non-rebreathing valve reusable Class IIa

Pulmonary function valve Pulmonary function valve Class IIa

Tube/mask breathing circuit connector reusable Tube/mask breathing circuit connector reusable Class IIa

Breathing mouthpiece reusable Breathing mouthpiece reusable Class IIa

CPAP/BPAP face mask reusable CPAP/BPAP face mask reusable Class IIa

CPAP/BPAP face mask single-use CPAP/BPAP face mask single-use Class IIa

Tube/mask breathing circuit connector single-use non-sterile Tube/mask breathing circuit connector single-use non-sterile Class IIa

Spirometer/pulmonary function analyser syringe Spirometer/pulmonary function analyser syringe Class I

Dressing-fixation skin adhesive tape non-silicone Dressing-fixation skin adhesive tape non-silicone Class I

Nose clip single-use Nose clip single-use Class I

Nose clip reusable Nose clip reusable Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Exhaled-gas sample collector non-electronic	Exhaled-gas sample collector non-electronic	Class IIa
Pneumotachograph	Pneumotachograph	Class IIa
Non-rebreathing valve reusable	Non-rebreathing valve reusable	Class IIa
Pulmonary function valve	Pulmonary function valve	Class IIa
Tube/mask breathing circuit connector reusable	Tube/mask breathing circuit connector reusable	Class IIa
Breathing mouthpiece reusable	Breathing mouthpiece reusable	Class IIa
CPAP/BPAP face mask reusable	CPAP/BPAP face mask reusable	Class IIa
CPAP/BPAP face mask single-use	CPAP/BPAP face mask single-use	Class IIa
Tube/mask breathing circuit connector single-use non-sterile	Tube/mask breathing circuit connector single-use non-sterile	Class IIa
Spirometer/pulmonary function analyser syringe	Spirometer/pulmonary function analyser syringe	Class I
Dressing-fixation skin adhesive tape non-silicone	Dressing-fixation skin adhesive tape non-silicone	Class I
Nose clip single-use	Nose clip single-use	Class I
Nose clip reusable	Nose clip reusable	Class I