SOL-M Luer Lock Syringe with Exchangeable Needle Tray
by Sol-Millennium Medical, Inc. 5 variants
Ref 1832110TModel Standard Luer Lock Syringe with Exchangeable Needle
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 | Number081006243SN32YV 00818392012880 | Date22 May 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00818392012880 | Date16 Sep 2016 | 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- Withdrawn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
- SOL-M Luer Lock Syringe with Exchangeable Needle Tray EUDAMEDSOL-M™ Luer Lock Syringe with Exchangeable Needle GUDID
- Generic Name
- General-purpose syringe, single-use
- Device Name
- SOL-M Luer Lock Syringe with Exchangeable Needle
- Model / Reference
- Standard Luer Lock Syringe with Exchangeable Needle, 1832110T
- Primary DI / UDI-DI
- 00818392012880 EUDAMED10818392012887 GUDID
- Basic UDI-DI
- 081006243SN32YV
- Direct Marketing DI
- 00818392012880
- FDA Product Code
- FMF
- EMDN Code
- A020102020101 Infusion and irrigation syringes, luer lock cone, 3-piece with needle, single-use
- GMDN Term
- General-purpose syringe, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5860
- EU market of registration
- Poland
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 25 MillimeterTotal Volume — 3 MilliliterNeedle Gauge — 21 Gauge
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 00818392012880 | 10818392012887 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000010890
- Authorised representative
- Sol-Millennium Europe Sp. z o.o. PL-AR-000010397
Other devices from Sol-Millennium Medical, Inc.
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: 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
- Manufacturing Date: No