Regulatory Information

Qlicksmart's Regulatory Commitment

Qlicksmart is accredited to ISO 13485, the International Standard for Quality Management System for medical device companies. In particular, our quality system complies with:
•FDA 21 CFR Part 820
•EC Council Directive 93/42/EEC as amended by Directive 2007/47/EC
•Compliant with Medical Device Regulation (EU) 2017/745
•Australian Therapeutic Goods Act 1989, Australia Therapeutic Goods Amendment (Medical Devices) Act 2002, and Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009.
We also vigorously advocate legislative change to integrate staff safety audits into the current independent accreditation programs for hospitals in Australia, the United States, the United Kingdom, Europe, and Asia.

Qlicksmart's Certificates

EN ISO 13485:2016

Qlicksmart maintains a Quality Management System which is verified under EN ISO 13485: 2016

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EC Certificate

Qlicksmart's Scalpel Blade Removers (Class Is) fulfil Annex V of Council Directive 93/42/EEC concerning medical devices

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Qlicksmart Products' Regulatory Information

Declarations of Conformity

General

Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
QFYGEN 46235 Body: ABS (Acrylonitrile Butadiene Styrene)

Inner mechanism: Polyacetal (POM), Stainless and Hardened Steel

No No No _ Single-use sharps container; each unit removes up to 100 blades Yes Packaging have been successfully tested in accordance with the provisions of the United Nations Transport of Dangerous Goods, Chapter 6
Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
QBVYGEN 46235 Body: ABS (Acrylonitrile Butadiene Styrene)

Inner Mechanism: ABS and Stainless Steel

No No No _ Single-use sharps container; each unit removes up to 100 blades Yes Packaging have been successfully tested in accordance with the provisions of the United Nations Transport of Dangerous Goods, Chapter 6

 

Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
QSSVCAS-3Y /QSSVCAS-3R 46236 Polypropylene (PP) No No Yes Gamma Single-use; each unit removes up to 3 blades Yes _

 

Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
QBN202S 46236 Needle counter box: High Impact Polystyrene

Cartridges: Polypropylene (PP)

No No Yes Gamma Single-use Yes _

 

Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
QSBS01 46236 Polypropylene (PP) No No Yes Gamma Single-use Yes _

 

Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
SN-01Rb (Blue)

SN-01Rp (Purple)

10098 Aluminium No No No _ Multi-use Yes _
Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
TE-01R (Regular)

TE-01L (Large)

TE-01XL (Extra Large)

10098 Aluminium No No No _ Multi-use Yes _
Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
SN-02R (Regular)

SN-02L (Large)

10098 ABS (Acrylonitrile Butadiene Styrene) No No No _ Multi-use Yes _

 

Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
For Vial: QSCCVIAL
For Ampoule: QSCCGEN
46240 Polypropylene (PP) No No No _ Single-use Yes _

United States

 

General FDA Classification Name Device Class 510(k) Number Product Code Regulation Number Compliant Standard/s
Qlicksmart BladeFLASK is FDA 510(K) premarket approved (# K983367) as a sharps container. container, sharps II K983367 MMK 880.557 OSHA Bloodborne Pathogene Standard "1910.1030"

 

General FDA Classification Name Device Class 510(k) Number Product Code Regulation Number Compliant Standard/s
Qlicksmart BladeFlask EVO is FDA listed. Blade, Scalpel I - GES 878.4800 OSHA Bloodborne Pathogene Standard "1910.1030"

 

General FDA Classification Name Device Class 510(k) Number Product Code Regulation Number Compliant Standard/s
Qlicksmart BladeCASSETTE is FDA listed. Blade, Sclapel I - GES 878.4800 OSHA Bloodborne Pathogene Standard "1910.1030"

 

General FDA Classification Name Device Class 510(k) Number Product Code Regulation Number Compliant Standard/s
Qlicksmart BladeNEEDLESYSTEM is FDA listed. Blade, Sclapel I - GES 878.4800 OSHA Bloodborne Pathogene Standard "1910.1030"
General FDA Classification Name Device Class 510(k) Number Product Code Regulation Number Compliant Standard/s
Qlicksmart BladeSINGLE is FDA listed. Blade, Sclapel I - GES 878.4800 OSHA Bloodborne Pathogene Standard "1910.1030"

 

General FDA Classification Name Device Class 510(k) Number Product Code Regulation Number Compliant Standard/s
Qlicksmart SnapIT is FDA listed. Surgical, General Use I - MDM 878.4800 -

 

General FDA Classification Name Device Class 510(k) Number Product Code Regulation Number Compliant Standard/s
Qlicksmart CheckCLIP is FDA listed. Labelling I - LYV 878.4800 -

UK/EU

 

Classification Rule Measuring Function Which MDD/AIMDD Annex(es) have been used for conformity assessment? CE Compliant/ Marked European Representative Italian Reportoire Number Notified Body Notified Body Details Notified Body Identification Number
Class I No Annex IV of Medical Device Regulation (EU) 2017/745 Yes Donawa Lifescience , Piazza Albania 10, 00153 Rome, Italy, P.IVA o VAT Number 10442731005 340114 No _ _

 

Classification Rule Measuring Function Which MDD/AIMDD Annex(es) have been used for conformity assessment? CE Compliant/ Marked European Representative Italian Reportoire Number Notified Body Notified Body Details Notified Body Identification Number
Class I No Annex IV of Medical Device Regulation (EU) 2017/745 Yes Donawa Lifescience , Piazza Albania 10, 00153 Rome, Italy, P.IVA o VAT Number 10442731005 10442731005 340114 No _ _

 

Classification Rule Measuring Function Which MDD/AIMDD Annex(es) have been used for conformity assessment? CE Compliant/ Marked European Representative Italian Reportoire Number Notified Body Notified Body Details Notified Body Identification Number
Class I Sterile No Annex V of Directive 93/42/EEC as amended by Directive 2007/47/EC Yes Donawa Lifescience Consulting Srl, Piazza Albania 10, 00153 Rome, Italy, P.IVA o VAT Number 10442731005 340117 Yes TÜV SÜD Product Service GmbH 0123
Classification Rule Measuring Function Which MDD/AIMDD Annex(es) have been used for conformity assessment? CE Compliant/ Marked European Representative Italian Reportoire Number Notified Body Notified Body Details Notified Body Identification Number
Class I Sterile No Annex V of Directive 93/42/EEC as amended by Directive 2007/47/EC Yes Donawa Lifescience Consulting Srl, Piazza Albania 10, 00153 Rome, Italy, P.IVA o VAT Number 10442731005 1399879 Yes TÜV SÜD Product Service GmbH 0123

 

Classification Rule Measuring Function Which MDD/AIMDD Annex(es) have been used for conformity assessment? CE Compliant/ Marked European Representative Italian Reportoire Number Notified Body Notified Body Details Notified Body Identification Number
Class I Sterile No Annex V of Directive 93/42/EEC as amended by Directive 2007/47/EC Yes Donawa Lifescience Consulting Srl, Piazza Albania 10, 00153 Rome, Italy, P.IVA o VAT Number 10442731005 1399874 Yes TÜV SÜD Product Service GmbH 0123

 

Classification Rule Measuring Function Which MDD/AIMDD Annex(es) have been used for conformity assessment? CE Compliant/ Marked European Representative Italian Reportoire Number Notified Body Notified Body Details Notified Body Identification Number
Not Applicable; not a medical device in Europe - - - - - Not Applicable - -

 

Classification Rule Measuring Function Which MDD/AIMDD Annex(es) have been used for conformity assessment? CE Compliant/ Marked European Representative Italian Reportoire Number Notified Body Notified Body Details Notified Body Identification Number
Not Applicable; not a medical device in Europe - - - - - Not Applicable - -

Australia/New Zealand

 

TGA ARTG No Compliant Standards for scalpel blade removal Which Australian Standards for sharps containers have been used for conformity assessment?
146821 AS 3825:2020 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles AS 4031-1992 Non-reusable containers for the collection of sharp medical items used in health care areas

 

 

TGA ARTG No Compliant Standards for scalpel blade removal Which Australian Standards for sharps containers have been used for conformity assessment?
146821 AS 3825:2020 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles AS 4031-1992 Non-reusable containers for the collection of sharp medical items used in health care areas

 

 

TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
134623 AS 3825:2020 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles n/a

 

TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
208058 AS 3825:2020 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles n/a

 

TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
134623 AS 3825:2020 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles n/a

 

TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
Not Applicable; not a medical device in Australia n/a n/a

 

TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
134522 n/a n/a

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