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BladeNeedleSYSTEM Non sterile Single Use Blade Remover
EUDAMEDFDA UDIClass I (EU MDR)
Ref QBNS202B
Identity
- Trade Name
- BladeNeedleSYSTEM Non sterile Single Use Blade Remover EUDAMEDBladeNeedleSYSTEM FDA UDI
- Generic Name
- Bile duct brachytherapy system applicator, manual FDA UDI
- Device Name
- Qlicksmart Single Use Scalpel Blade Removers Non-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
- QBNS202B 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
- 09337363001728 EUDAMEDFDA UDI
- Basic UDI-DI
- 93373630QSBRSNS0000149 EUDAMED
- FDA Product Code
- GAB FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Bile duct brachytherapy system applicator, manual 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
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
BladeNeedleSYSTEM Non sterile Single Use Blade Remover by Qlicksmart Pty Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 93373630QSBRSNS0000149 | 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 19e7d94d-3a2d-42b4-8275-e3d7d72bf46e 61 fields · synced Jul 30, 2026
- FDA UDI fba156c7-865c-4be0-9636-f1b4d14e1c21 35 fields · synced May 30, 2026