Sterile hypodermic syringe for single use with needle
by Wuxi Yushou Medical Appliances Co., Ltd. EUDAMEDGUDID
Active
Ref 100000000288Model three - piece,middle head luer lock connector,normal wall and long cutting edge
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697135228YZ03010001HK | Date24 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number06971352283592 | Date27 Mar 2021 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Sterile hypodermic syringe for single use with needle EUDAMEDYeso med GUDID
- Generic Name
- Hypodermic needle, single-use
- Model / Reference
- three - piece EUDAMEDmiddle head luer lock connector EUDAMEDnormal wall and long cutting edge EUDAMED100000000288 EUDAMED2ml 0.5×20 GUDID
- Primary DI / UDI-DI
- 06971352283592
- Basic UDI-DI
- 697135228YZ03010001HK
- FDA Product Code
- FMF, FMI
- EMDN Code
- A020102020101 Infusion and irrigation syringes, luer lock cone, 3-piece with needle, single-use
- GMDN Term
- Hypodermic needle, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5860, 880.5570
- Market of Registration
- Portugal
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | three - piece,middle head luer lock connector,normal wall and long cutting edge 100000000288 | 2ml 0.5×20 |
| 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
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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