Syringes for single use ( 5mL, Luer Slip )
by Jiangxi Hongda Medical Equipment Group Ltd.
Ref S05S0000Model 1mL、2mL、2.5 mL、3 mL、5 mL、10 mL、20 mL、30 mL、50 mL、60 mL、100 mL
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69207567ZSQ0001ZR 06920756728475 | Date16 Feb 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06920756728475 | Date29 Mar 2021 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Syringes for single use ( 5mL, Luer Slip ) 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 EUDAMEDS05S0000 EUDAMED5mL LS GUDID
- Primary DI / UDI-DI
- 06920756728475
- 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
- EU market of registration
- Italy
- GUDID distribution status
- 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 S05S0000 | 5mL LS |
| 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
Other devices from Jiangxi Hongda Medical Equipment Group Co., Ltd.
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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