SOL-M Catheter Tip Syringe
by Sol-Millennium Medical, Inc. EUDAMED
Active
Ref 180060CTBS, 180100CTBS, IRS002Model Catheter Tip Syringe
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081006243ORL11WQ | Date1 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Trade Name
- SOL-M Catheter Tip SyringeSOL-M Catheter Tip Syringe with Luer Adapter
- Model / Reference
- Catheter Tip Syringe, 180060CTBS, 180100CTBS, IRS002
- Primary DI / UDI-DI
- 00810018095253, 00810018095260, 00840368500008
- Basic UDI-DI
- 081006243ORL11WQ
- Direct Marketing DI
- 008100180952530081001809526000840368500008
- EMDN Code
- A02010203 Infusion and irrigation syringes, catheter cone, single-use
- Device Class
- Class I
- Market of Registration
- Poland
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 (10)
- 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