Safety syringe with needle
by Wuxi Yushou Medical Appliances Co., Ltd. 25 variants
Ref 100300000049Model 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 | Number697135228AZ030100EQ 06971352283486 | Date23 May 2024 | StatusActive |
| United States | GUDID listing GUDID | Number06971352283486 | 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- Withdrawn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
- normal wall and long cutting edge EUDAMED100300000049 EUDAMED1ml 27G×1/2" (0.4×12.7) GUDID
- Primary DI / UDI-DI
- 06971352283486
- 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
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | normal wall and long cutting edge 100300000049 | 1ml 27G×1/2" (0.4×12.7) |
| 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
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