Sterile hypodermic syringe for single use with needle
by Wuxi Yushou Medical Appliances Co., Ltd. 101 variants
Ref 100000000250Model three - piece,middle head and a luer slip connector,thin-walled 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 | Number697135228YZ03000003HC 06971352282489 | Date16 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number06971352282489 | Date31 Mar 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- Withdrawn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
- Sterile hypodermic syringe for single use with needle EUDAMEDYeso med GUDID
- Generic Name
- Hypodermic needle, single-use
- Model / Reference
- three - piece EUDAMEDmiddle head and a luer slip connector EUDAMEDthin-walled and long cutting edge EUDAMED100000000250 EUDAMED2.5ml 0.6×32 GUDID
- Primary DI / UDI-DI
- 06971352282489
- Basic UDI-DI
- 697135228YZ03000003HC
- FDA Product Code
- FMF, FMI
- EMDN Code
- A020102010201 Infusion and irrigation syringes, luer 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
- EU market of registration
- Portugal
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| 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