Quality Standards

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

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

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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

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

Korean GMP

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UKCA Certificate

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TPED EU TYPE-EXAMINATION CERTIFICATES

• TPED 15-1006198-100 In-line Cylinder Valves with rotating design-GII.pdf
• TPED 15-1006198-101 Off-line Cylinder valves with rotating design-GII.pdf
• TPED 17-1008175-105 Chlorine Cylinder Valve
• TPED 18-1008175-110 Charging valve.pdf
• TPED 19-1008175-114 Valve for small cylinders.pdf
• TPED 20-1008154-118 Diaphragm valve.pdf
• TPED 21-1008175-125 Rev. 0 BV300.pdf
• TPED 22-1008175 Rev 0 SMV.pdf
• TPED 22-1008175 Rev 0 IVC.pdf
• TPED 22-1008175-130 Rev 0 Pin-index.pdf 
• TPED 22-1008175-132 Rev 0 Ministar 2 - E-Ministar - MediVitop.pdf
• TPED 22-1008175-133 Rev 0 MediVital, MediVital E.pdf
• TPED 22-1008175-134 Rev 0 CV Caeli Nova.pdf
• TPED 23-1008175-137 Rev 0 CV Combi-Helium.pdf

TPED DECLARATION OF CONFORMITY

• DoC TPED_12-466227-01_Rev. 1
• DoC TPED_12-466227-02_Rev. 0
• DoC TPED_12-466227-03_Rev. 0
• DoC TPED_12-466227-04_Rev. 3
• DoC TPED_12-466227-06_Rev. 2
• DoC TPED_12-466227-07 Rev. 0
• DoC TPED_12-466227-09_Rev. 0
• DoC TPED_12-466227-11_Rev. 5
• DoC TPED_12-466227-12_Rev. 3
• DoC TPED_15-1006198-100_Rev. 4
• DoC TPED_15-1006198-101_Rev. 4
• DoC TPED_17-1008175-105_Rev. 0
• DoC TPED_18-1008175-110_Rev. 1
• DoC TPED_19-1008175-114_Rev. 0
• DoC TPED_20-1008175-118_Rev. 1
• DoC TPED_21-1008175-125_Rev. 0
• DoC TPED_22-1008175-129_Rev. 0
• DoC TPED_22-1008175-130_Rev. 0
• DoC TPED_22-1008175-131_Rev. 0
• DoC TPED_22-1008175-132_Rev. 0
• DoC TPED_22-1008175-133_Rev. 0
• DoC TPED_23-1008175-137_Rev. 0

DNV CERTIFICATES - MDR

• Medical gas Tube Flowmeter
• Pressure Regulator Integrated with Cylinder Valves
• Pin-Index Valve

DECLARATION OF CONFORMITY MEDICAL DEVICES - MDR

• TF ZP 21-040 Tube Flowmeter
• TF ZP 21-038 Pin-Index Valve EN
• TF ZP 22-044 Pressure regulators integrated with cylinder valves EN
• TF ZP 22-044 Pressure regulators integrated with cylinder valves CZ

DECLARATION OF CONFORMITY MEDICAL DEVICES

• TF_01_004 - Cylinder Valves
• TF_02_005 - Pressure regulators integrated with cylinder valves
• TF_03_006 - High pressure regulators
• TF_04_007 - Suction equipment
• TF_05_009 - Low pressure regulators
• TF_06_011 - Terminal unit
• TF_06_012 - Low pressure hoses
• TF_06_014 - Flow-metering device
• TF_06_015 - Central gas supply system
• TF_08_017 - Demand valve
• TF_08_019 - Humidifiers
• TF_10_023 - Central gas supply system - Shut off valve systems
• TF_10_024 - Central gas supply system - Pressure monitor
• TF_10_025 - Gas saver
• TF_12_026 - Ambulance Panel II
• TF_15_028 - MARS II
• TF_15_029 - Adjustable Regulators
• TF_21_031 - MediCollect
• TF_21_032 - MediCollect Bag
• REG 00079 Rev. 14 - GCE POC
• TF_21_034 - Terminal Units IIa

CERTIFICATE OF CONFORMITY

• Quick Couplings
• Cylinder Regulators
• Non-return Valves
• Flashback Arrestors
• Cutting and Welding Technologies

DECLARATION OF COMPATIBILITY

• Ambulance Panel System
• System Pressure Monitor
• System MED Manifold

UK Rho CERTIFICATES

• AIS-CDG-1266-340-20221107 TPE Certificate of Authorisation GCE Signed SD
• 1266-340-2303 Combi-helium
• 1266-340-2209 BV 300
• 1266-340-2208 Diaphragm valve
• 1266-340-2207 Charging valve
• 1266-340-2206 IVC
• 1266-340-2205 Off-Line cylinder valves
• 1266-340-2204 In-Line cylinder valves
• 1266-340-2203 Pin Index
• 1266-340-2202 Ministar, MediVitop
• 1266-340-2201 MediVita, MediVital E

DECLARATION OF CONFORMITY UK Rho

• TAC-1266-340-2201 MediVital, MediVital E
• TAC-1266-340-2202 Ministar, MediVitop
• TAC-1266-340-2203 Pin Index
• TAC-1266-340-2204 In line CV rotating design - GII
• TAC-1266-340-2205-1 Off line CV rotating design - GII
• TAC-1266-340-2206 issued on 2024-11-14 IVC Valves - Combi
• TAC-1266-340-2207 issued on 2023-11-14 Cylinder Valves - Charging Valve
• TAC-1266-340-2208 issued on 2023-11-14 Cylinder Valve - DIAPHRAGM VALVE
• TAC-1266-340-2209 issued on 2023-11-14 Shut-off valves BV300
• TAC-1266-340-2303 issued on 2023-11-14 CV Combi-Helium