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
•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

General

BladeFLASK
Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
QFYGEN 46235 Body: ABS (Acrylnonitirle Butadiene Styrene) Inner mechanism: Polyacetal (POM) 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
BladeCASSETTE
 
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 _
BladeNeedleSYSTEM
 
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 _
BladeSINGLE
 
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 _
SnapIT
 
Product Code GMDN Code Material Latex DEHP Sterile Method of sterilization Re-usable EAN Number Packaging
Refer to the brochure 10098 Refer to the brochure No No No _ Multi-use Yes _
CheckCLIP
 
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

BladeFLASK
 
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"
BladeCASSETTE
 
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"
BladeNeedleSYSTEM
 
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"
BladeSINGLE
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"
SnapIT
 
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 -
CheckCLIP
 
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

BladeFLASK
 
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 VII 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 340114 No _ _
BladeCASSETTE
 
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 DQS Medzinprodukte GmbH 0297
BladeNeedleSYSTEM
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 DQS Medzinprodukte GmbH 0297
BladeSINGLE
 
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 DQS Medzinprodukte GmbH 0297
SnapIT
 
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 Applicable - -
CheckCLIP
 
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 Applicable - -
Declaration of Conformity

 

BladeFLASK Click here to download
Single Use Scalpel Blade Removers Click here to download

 

Australia/New Zealand

BladeFLASK
 
TGA ARTG No Compliant Standards for scalpel blade removal Which Australian Standards for sharps containers have been used for conformity assessment?
146821 AS/NZS 3825:1998 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
 
BladeCASSETTE
 
TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
134623 AS/NZS 3825:1998 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles n/a
BladeNeedleSYSTEM
 
TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
208058 AS/NZS 3825:1998 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles n/a
BladeSINGLE
 
TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
134623 AS/NZS 3825:1998 Procedures and devices for the removal and disposal of scalpel blades from scalpel handles n/a
SnapIT
 
TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
Not Applicable n/a n/a
CheckCLIP
 
TGA ARTG No Compliant Standard/s Which Australian Standards for sharps containers have been used for conformity assessment?
134522 n/a n/a
Declaration of Conformity

 

BladeFLASK Click here to download
Single Use Scalpel Blade Removers Click here to download
SnapIT Click here to download
CheckCLIP Click here to download

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