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
Click HereEC Certificate
Qlicksmart's Scalpel Blade Removers (Class Is) fulfil Annex V of Council Directive 93/42/EEC concerning medical devices
Click HereFrequently Asked Questions for Hospital Tenders
Qlicksmart Products' Regulatory Information
Declarations of Conformity
BladeFLASK & BladeFlask EVO
Single-Use Scalpel Blade Removers (Sterile)
Single-Use Scalpel Blade Removers (Non-sterile)
SnapIT ampoule openers
CheckCLIP Medication ID
General
BladeFLASK
|
Product Code |
GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
International Standards (ISO) used for conformity assessment |
|
QFYGEN |
46235 |
Body: ABS (Acrylonitrile Butadiene Styrene)
Inner mechanism: Polyacetal (POM), Stainless and Hardened Steel |
No |
No | No |
– |
Single-use sharps container; unit removes up to 100 blades |
Yes |
Independently tested by a NATA accredited laboratory in accordance with the provisions of the United Nations Transport of Dangerous Goods, Chapter 6 | ISO23901.1 - Sharps Injury Protection |
BladeFlask EVO
|
Product Code |
GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
International Standards (ISO) used for conformity assessment |
|
QBVYGEN |
46235 |
Body: ABS (Acrylonitrile Butadiene Styrene)
Inner mechanism: ABS and Stainless Steel |
No |
No |
No |
– |
Single-use sharps container; unit removes up to 100 blades |
Yes |
Independently tested by a NATA accredited laboratory in accordance with the provisions of the United Nations Transport of Dangerous Goods, Chapter 6 | ISO23901.1 - Sharps Injury Protection |
BladeCASSETTE
|
Product Code |
GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
International Standards (ISO) used for conformity assessment |
| QSSVCAS-3Y QSSVCAS-3R |
46236 |
Polypropylene (PP) |
No |
No |
Yes |
Gamma |
Single-use; unit removes up to 3 blades |
Yes |
- | The Australian Standard 3825:2020, Procedures and devices for the removal, containment, and disposal of scalpel blades from scalpel handles |
BladeNeedleSYSTEM
|
Product Code |
GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
International Standards (ISO) used for conformity assessment |
| QBN202S QBNS202R |
46236 |
Polypropylene (PP) |
No |
No |
Yes |
Gamma |
Single-use; unit removes up to 2 blades |
Yes |
- | The Australian Standard 3825:2020, Procedures and devices for the removal, containment, and disposal of scalpel blades from scalpel handles |
BladeSINGLE
|
Product Code |
GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
International Standards (ISO) used for conformity assessment |
| QSBS01 |
46236 |
Polypropylene (PP) |
No |
No |
Yes |
Gamma |
Single-use |
Yes |
- | The Australian Standard 3825:2020, Procedures and devices for the removal, containment, and disposal of scalpel blades from scalpel handles |
SnapIT Personal
| Product Code | GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
| SN-01Rb (Blue)
SN-01Rp (Purple) |
10098 | Body: Aluminium
Spring and keyring: Stainless Steel O-Ring: Silicon |
No | No | No | _ | Multi-use | Yes | _ |
SnapIT Trolley
| 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 | Body: Aluminium
Spring and keyring: Stainless Steel O-Ring: Silicon |
No | No | No | _ | Multi-use | Yes | _ |
SnapIT Lite
| Product Code | GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
| SN-02R (Regular)
SN-02L (Large) |
10098 | Body: ABS (Acrylonitrile Butadiene Styrene)
Spring and keyring: Stainless Steel O-Ring: Silicon |
No | No | No | _ | Multi-use | Yes | _ |
CheckCLIP
| Product Code | GMDN Code | Material | Latex | DEHP | Sterile | Method of sterilization | Re-usable | EAN Number | Packaging |
| QSCCVIAL (For vial)
QSCCGEN (For ampoule) |
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 | Enables Compliance with Standard |
| Qlicksmart BladeFLASK is FDA 510(K) premarket approved as a sharps container | container, sharps | II | K983367 | MMK | 880.557 | OSHA's Bloodborne Pathogens Standard - CFR 1910.1030 |
BladeFlask EVO
| General | FDA Classification Name | Device Class | 510(k) Number | Product Code | Regulation Number | Enables Compliance with Standard |
| Qlicksmart BladeFlask EVO is FDA 510(K) premarket approved as a sharps container | container, sharps | II | K213274 | MMK | 880.557 | OSHA's Bloodborne Pathogens Standard - CFR 1910.1030 |
BladeCASSETTE
| General | FDA Classification Name | Device Class | 510(k) Number | Product Code | Regulation Number | Enables Compliance with Standard |
| Qlicksmart BladeCASSETTE is FDA listed | Blade, Scalpel | I | - | GES | 878.4800 |
OSHA's Bloodborne Pathogens Standard - CFR 1910.1030 |
BladeNeedleSYSTEM
| General | FDA Classification Name | Device Class | 510(k) Number | Product Code | Regulation Number | Enables Compliance with Standard |
| Qlicksmart BladeNeedleSYSTEM is FDA listed | Blade, Scalpel | I | - | GAB | 878.4800 | OSHA's Bloodborne Pathogens Standard - CFR 1910.1030 |
BladeSINGLE
| General | FDA Classification Name | Device Class | 510(k) Number | Product Code | Regulation Number | Enables Compliance with Standard |
| Qlicksmart BladeSINGLE is FDA listed | Blade, Scalpel | I | - | GES | 878.4800 | OSHA's Bloodborne Pathogens Standard - CFR 1910.1030 |
SnapIT
| General | FDA Classification Name | Device Class | 510(k) Number | Product Code | Regulation Number | Enables Compliance with Standard |
| Qlicksmart SnapIT is FDA listed | Labelling, General Use | I | - | MDM | 878.4800 | - |
CheckCLIP
| General | FDA Classification Name | Device Class | 510(k) Number | Product Code | Regulation Number | Enables Compliance with Standard |
| Qlicksmart CheckCLIP is FDA listed | Labelling | I | - | LYV | 878.4800 | - |
UK/EU
BladeFLASK
| Classification Rule | Measuring Function | Which European regulation 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
Annex IX (as modified by part II of schedule 2A to the UK MDR 2002) |
Yes | Donawa Lifescience , Piazza Albania 10, 00153 Rome, Italy, P.IVA o VAT Number 10442731005 | 340114 | No | _ | _ |
BladeFlask EVO
| Classification Rule | Measuring Function | Which European regulation 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
Annex IX (as modified by part II of schedule 2A to the UK MDR 2002) |
Yes | Donawa Lifescience , Piazza Albania 10, 00153 Rome, Italy, P.IVA o VAT Number 10442731005 10442731005 | 340114 | No | _ | _ |
BladeCASSETTE
| Classification Rule | Measuring Function | Which European regulation 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 |
BladeNeedleSYSTEM
| Classification Rule | Measuring Function | Which European regulation 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 |
BladeSINGLE
| Classification Rule | Measuring Function | Which European regulation 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 |
SnapIT
| Classification Rule | Measuring Function | Which European regulation 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 | - | - |
CheckCLIP
| Classification Rule | Measuring Function | Which European regulation 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
BladeFLASK
| TGA ARTG No | Compliant Standards for scalpel blade removal | Which Australian Standards for sharps containers have been used for conformity assessment? |
| 146821 | Independently tested by a NATA approved laboratory for compliance with AS 3825:2020 Standard “Procedures and devices for the removal and disposal of scalpel blades from scalpel handles” | Independently tested by a NATA approved laboratory for compliance with AS 4031-1992 Non-reusable containers for the collection of sharp medical items used in health care areas |
BladeFlask EVO
| TGA ARTG No | Compliant Standards for scalpel blade removal | Which Australian Standards for sharps containers have been used for conformity assessment? |
| 146821 | Independently tested by a NATA approved laboratory for compliance with AS 3825:2020 Standard “Procedures and devices for the removal and disposal of scalpel blades from scalpel handles” | Independently tested by a NATA approved laboratory for compliance with 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 | Independently tested by a NATA approved laboratory for compliance with AS 3825:2020 Standard “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 | Independently tested by a NATA approved laboratory for compliance with AS 3825:2020 Standard “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 | Independently tested by a NATA approved laboratory for compliance with AS 3825:2020 Standard “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; not a medical device in Australia | 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 |
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