SOL-M Catheter Tip Syringe
by Sol-Millennium Medical, Inc. EUDAMEDGUDID
Active
Ref 180060CTModel Catheter Tip Syringe
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number081006243ORL11WQ | Date1 Jun 2023 | StatusActive |
| United States | GUDID listing GUDID | Number10818392010319 | Date23 Oct 2017 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Trade Name
- SOL-M Catheter Tip Syringe EUDAMEDSOL-M™ Catheter Tip Syringe w/o Needle GUDID
- Generic Name
- General-purpose syringe, single-use
- Model / Reference
- Catheter Tip Syringe, 180060CT
- Primary DI / UDI-DI
- 10818392010319 EUDAMED00818392010312 GUDID
- Basic UDI-DI
- 081006243ORL11WQ
- Direct Marketing DI
- 10818392010319
- FDA Product Code
- KYZ
- EMDN Code
- A02010203 Infusion and irrigation syringes, catheter cone, single-use
- GMDN Term
- General-purpose syringe, single-use
- Device Class
- Class I
- Regulation Number
- 880.6960
- Market of Registration
- Poland
- Commercial Distribution
- In Commercial Distribution
- Size
- Total Volume — 60 Milliliter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 10818392010319 | 00818392010312 |
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 (18)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No