GBUK Sterile Syringe
by Jiangsu Micsafe Medical Technology Co., Ltd 7 variants
Ref 3PLS010, 3PLS001, 3PLS030, 3PLL001, 3PLS020, 3PLL060, 3PLL010, 3PLL005, 3PLL030, 3PLL020Model 10ml luer slip, 1ml,Luer Slip, 30ml luer slip, 3ml luer lock, 20ml luer slip, 1ml,luer slip, 60ml, Luer Lock, 10ml, Luer Lock, 1ml, Luer Lock, 5ml, Luer Lock, 30ml, Luer Lock, 20ml, Luer Lock
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-16971911299214 | Date28 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number16971911299214 | Date20 May 2021 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- GBUK Sterile Syringe EUDAMEDGBUK Sterle Syringe EUDAMEDGbuk GUDID
- Generic Name
- General-purpose syringe, single-use
- Model / Reference
- 10ml luer slip EUDAMED3PLS010 EUDAMED1ml EUDAMEDLuer Slip EUDAMED3PLS001 EUDAMED30ml luer slip EUDAMED3PLS030 EUDAMED3ml luer lock EUDAMED3PLL001 EUDAMED20ml luer slip EUDAMED3PLS020 EUDAMED60ml EUDAMEDLuer Lock EUDAMED3PLL060 EUDAMED10ml EUDAMED3PLL010 EUDAMED5ml EUDAMED3PLL005 EUDAMED30ml EUDAMED3PLL030 EUDAMED20ml EUDAMED3PLL020 EUDAMED1 GUDID
- Primary DI / UDI-DI
- 16971911299214, 26971911299181, 16971911299238, 26971911299266, 16971911299221, 06971911299224, 16971911299269, 26971911299228, 16971911299184, 06971911299262, 06971911299323, 26971911299297, 26971911299327, 16971911299276, 06971911299286, 16971911299313, 26971911299280, 16971911299283, 16971911299290, 06971911299316, 16971911299320, 16971911299306, 26971911299273, 06971911299293, 26971911299310
- Basic UDI-DI
- B-16971911299214, B-26971911299181, B-16971911299238, B-26971911299266, B-16971911299221, B-06971911299224, B-16971911299269, B-26971911299228, B-16971911299184, B-06971911299262, B-06971911299323, B-26971911299297, B-26971911299327, B-16971911299276, B-06971911299286, B-16971911299313, B-26971911299280, B-16971911299283, B-16971911299290, B-06971911299316, B-16971911299320, B-16971911299306, B-26971911299273, B-06971911299293, B-26971911299310
- FDA Product Code
- FMI, MEG, FMF
- EMDN Code
- A020102010202, A020102020102
- GMDN Term
- General-purpose syringe, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5570, 880.5860
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 10ml luer slip 3PLS010 1ml,Luer Slip 3PLS001 30ml luer slip 3PLS030 3ml luer lock 3PLL001 20ml luer slip 3PLS020 60ml, Luer Lock 3PLL060 10ml, Luer Lock 3PLL010 1ml, Luer Lock 5ml, Luer Lock 3PLL005 30ml, Luer Lock 3PLL030 20ml, Luer Lock 3PLL020 | 1 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000011594
- Authorised representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
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Properties
Other properties (15)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No