SOL-M Luer Lock Syringe with Blunt Fill Needle
by Sol-Millennium Medical, Inc. 3 variants
Ref 1811815BModel Standard Luer Lock Syringe with Blunt Fill 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 | Number081006243SN318TW 00818392011616 | Date1 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00818392011616 | 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- Withdrawn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
- Generic Name
- General-purpose syringe, single-use
- Model / Reference
- Standard Luer Lock Syringe with Blunt Fill Needle, 1811815B
- Primary DI / UDI-DI
- 00818392011616
- Basic UDI-DI
- 081006243SN318TW
- Direct Marketing DI
- 00818392011616
- FDA Product Code
- FMF, FMI, MEG
- 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 I EUDAMEDClass II GUDID
- Regulation Number
- 880.5860, 880.5570
- EU market of registration
- Poland
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 18 GaugeTotal Volume — 10 MilliliterLength — 40 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | 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