BladeSINGLE Non Sterile Blade Remover
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- BladeSINGLE Non Sterile Blade Remover EUDAMEDBladeSINGLE FDA UDI
- Generic Name
- Bile duct brachytherapy system applicator, manual FDA UDI
- Device Name
- Qlicksmart Single Use Scalpel Blade Removers Non-Sterile EUDAMEDThe Qlicksmart BladeSINGLE scalpel blade remover is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades. Used together with a hands-free passing technique, the Qlicksmart BladeSINGLE scalpel blade remover can prevent up to 5 times more injuries than a safety scalpel. This easy-to-use solution provides a low cost alternative to safety scalpels, allowing surgeons to maintain their preferences for the standard metal handle. FDA UDI
- Model / Reference
- QSBS01-B EUDAMEDFDA UDI
- Description
- The Qlicksmart BladeSINGLE scalpel blade remover is simple to use with a quick “push, click, and pull” action to remove and contain used scalpel blades. Used together with a hands-free passing technique, the Qlicksmart BladeSINGLE scalpel blade remover can prevent up to 5 times more injuries than a safety scalpel. This easy-to-use solution provides a low cost alternative to safety scalpels, allowing surgeons to maintain their preferences for the standard metal handle. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09337363001704 EUDAMEDFDA UDI
- Basic UDI-DI
- 93373630QSBRSNS0000149 EUDAMED
- FDA Product Code
- GES 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
BladeSINGLE Non Sterile Blade Remover by Qlicksmart Pty Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 965a8873-ecdc-4eac-ae22-eee8b212f1f6 61 fields · synced Jul 9, 2026
- FDA UDI 80108a59-35b1-45e4-9e5e-965d4f6da1a5 34 fields · synced May 30, 2026