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 Quality Standards

ISO 9001:2015 ISO 14001:2015 ISO 45001:2018

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ISO 13485:2016

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Medical Devices for use
with Medical Gases

Included with Notified Confirmation Letter

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TPED/ADR

 In-house inspection service certificate 2023

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ABS CERTIFICATE - Manifold

 

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EC CERTIFICATE FOR POC

Included with Notified Confirmation Letter

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REGULATION EC 
No. 1935_2004

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APPENDIX TO
EC CERTIFICATE

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MDR Certificate
Medical Gas Tube Flowmeter

 

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MDR Certificate
Pressure Regulator Integrated with Cylinder Valve

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MDR Certificate Pin-Index Valve

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ABS CERTIFICATE - Pipe Extension Joint

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CERTIFICATE of ACCREDITATION

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Korean GMP

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UKCA Certificate

 

UKCA Certificate 2023 - 2028 

 

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TPED EU TYPE-EXAMINATION CERTIFICATES

TPED DECLARATION OF CONFORMITY

DNV CERTIFICATES - MDR

DECLARATION OF CONFORMITY MEDICAL DEVICES - MDR

DECLARATION OF CONFORMITY MEDICAL DEVICES

CERTIFICATE OF CONFORMITY

DECLARATION OF COMPATIBILITY

UK Rho CERTIFICATES

DECLARATION OF CONFORMITY UK Rho

 

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