Safety syringe with needle
by Wuxi Yushou Medical Appliances Co., Ltd. China EUDAMEDGUDID
Ref 100300000055Model normal wall and long cutting edge
Product code FMIEMDN A02010205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697135228AZ030100EQ | Date23 May 2024 | StatusActive |
| United States | GUDID listing GUDID | Number06971352283462 | Date1 Apr 2021 | StatusIn distribution |
Coverage
- Active
- 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
- normal wall and long cutting edge EUDAMED100300000055 EUDAMED1ml 29G×1/2" ( 0.33×12.7) GUDID
- Primary DI / UDI-DI
- 06971352283462
- Basic UDI-DI
- 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
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | normal wall and long cutting edge 100300000055 | 1ml 29G×1/2" ( 0.33×12.7) |
| 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 & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 1120faef-c917-436a-ba3e-735fee3cc5ad
- FDA UDI e892ef56-8ec0-4399-b1ec-1af109e79840