Safety syringe with needle
by Wuxi Yushou Medical Appliances Co., Ltd. 25 variants
Ref 100600000060, 100200000075, 100600000054, 100600000053, 100200000066, 100200000069, 100600000057, 100200000072, 100200000059, 100200000074, 100600000050, 100600000061, 100600000032, 100200000011, 100200000061, 100200000013, 100600000052, 100200000004, 100300000046, 100300000036Model thin-walled and long cutting edge, normal wall and long cutting edge
Active
CE MDR
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/MDR EUDAMED | Number697135228AZ030001EM | Date23 May 2024 | StatusActive |
| United States | GUDID listing GUDID | Number06975442096284 | Date1 Apr 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- Withdrawn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
- Yeso med
- Generic Name
- Hypodermic needle, single-use
- Device Name
- Safety syringe with needle
- Model / Reference
- thin-walled and long cutting edge EUDAMED100600000060 EUDAMED100200000075 EUDAMED100600000054 EUDAMED100600000053 EUDAMED100200000066 EUDAMED100200000069 EUDAMED100600000057 EUDAMED100200000072 EUDAMED100200000059 EUDAMED100200000074 EUDAMED100600000050 EUDAMED100600000061 EUDAMED100600000032 EUDAMEDnormal wall and long cutting edge EUDAMED100200000011 EUDAMED100200000061 EUDAMED100200000013 EUDAMED100600000052 EUDAMED100200000004 EUDAMED100300000046 EUDAMED100300000036 EUDAMED1ml 30G×1/2" (0.3×12) GUDID1ml 30G×5/16" (0.3×7.9) GUDID10ml 22G×1 1/2" (0.7×38) GUDID
- Primary DI / UDI-DI
- 06975442096284, 06976272566701, 06975442096222, 06975442096215, 06976272566619, 06976272566640, 06975442096253, 06976272566671, 06976272566541, 06976272566695, 06975442096185, 06975442096291, 06971352285862, 06976272566435, 06976272566565, 06976272566466, 06971352285527, 06971352285510, 06975442096208, 06976272566473
- Basic UDI-DI
- 697135228AZ030001EM, 697135228AZ000002DN, 697135228AZ030003ER, 697135228AZ000101DR, 697135228AZ000001DL, 697135228AZ030100EQ
- FDA Product Code
- FMI
- EMDN Code
- A02010205 Infusion and irrigation syringes with safety system, single-use
- GMDN Term
- Hypodermic needle, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5570
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | thin-walled and long cutting edge 100600000060 100200000075 100600000054 100600000053 100200000066 100200000069 100600000057 100200000072 100200000059 100200000074 100600000050 100600000061 100600000032 normal wall and long cutting edge 100200000011 100200000061 100200000013 100600000052 100200000004 100300000046 100300000036 | 1ml 30G×1/2" (0.3×12) 1ml 30G×5/16" (0.3×7.9) 10ml 22G×1 1/2" (0.7×38) |
| Device Class | Class IIa | Class II |
| Implantable | Yes | No |
Manufacturer details
- EUDAMED SRN
- CN-MF-000017951
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Wuxi Yushou Medical Appliances Co., Ltd.
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Properties
Other properties (16)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No