Identity
- Trade Name
- BladeNeedleSYSTEM Sterile EUDAMEDBladeNeedleSYSTEM FDA UDI
- Generic Name
- Scalpel blade remover, sterile FDA UDI
- Device Name
- Qlicksmart Scalpel Blade Remover Single Use Sterile EUDAMEDThe Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count and efficient disposal of both scalpel blades and suture needles. FDA UDI
- Model / Reference
- QBNS202S EUDAMEDFDA UDI
- Description
- The Qlicksmart BladeNeedleSYSTEM is two safety devices in one – the world’s only single-handed scalpel blade remover is combined with the standard needle counter to allow an accurate count and efficient disposal of both scalpel blades and suture needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09337363001674 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09337363001674 EUDAMED
- FDA Product Code
- GAB FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Scalpel blade remover, sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
BladeNeedleSYSTEM Sterile by Qlicksmart Pty Ltd — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09337363001674 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qlicksmart Pty Ltd
- EUDAMED SRN
- AU-MF-000033870
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (2)
- EUDAMED b8d490bc-92ca-4446-a286-c587d11516ab 61 fields · synced Jul 9, 2026
- FDA UDI 0cfef6e9-d660-4811-b899-ae02ee0ba604 35 fields · synced May 30, 2026