Syringes for single use ( 3mL, Luer Lock )
by Jiangxi Hongda Medical Equipment Group Ltd. EUDAMEDGUDID
Active
Ref S03L0000Model 1mL、2mL、2.5 mL、3 mL、5 mL、10 mL、20 mL、30 mL、50 mL、60 mL、100 mL
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69207567ZSQ0001ZR | Date16 Feb 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06920756728420 | Date29 Mar 2021 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Syringes for single use ( 3mL, Luer Lock ) EUDAMEDSterile Single-use Syringe with Needle GUDID
- Generic Name
- General-purpose syringe/needle
- Device Name
- Syringes for single use
- Model / Reference
- 1mL、2mL、2.5 mL、3 mL、5 mL、10 mL、20 mL、30 mL、50 mL、60 mL、100 mL EUDAMEDS03L0000 EUDAMED3mL LL GUDID
- Primary DI / UDI-DI
- 06920756728420
- Basic UDI-DI
- 69207567ZSQ0001ZR
- 510(k) Number
- FDA Product Code
- FMI, FMF
- EMDN Code
- A02010499 Syringes for injector, single-use - other
- GMDN Term
- General-purpose syringe/needle
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5570, 880.5860
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 1mL、2mL、2.5 mL、3 mL、5 mL、10 mL、20 mL、30 mL、50 mL、60 mL、100 mL S03L0000 | 3mL LL |
| Device Class | Class IIa | Class II |
| Contains Latex | Yes | No |
Manufacturer details
- EUDAMED SRN
- CN-MF-000006019
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (15)
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No