SOL-GUARD Insulin Safety Syringe with Fixed Needle
by Sol-Millennium Medical, Inc. EUDAMED
Active
Ref 200094SG, 23316SG, 25306SG, 233105SG, 25316SG, 200093SG, 2530516SGModel Insulin Safety Syringe with Fixed Needle (Shield Technology)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081006243SIG1ZT | Date8 Jan 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Insulin Safety Syringe with Fixed Needle (Shield Technology), 200094SG, 23316SG, 25306SG, 233105SG, 25316SG, 200093SG, 2530516SG
- Primary DI / UDI-DI
- 00818392013801, 00818392016048, 00818392016024, 00818392013641, 00818392016017, 00818392015997, 00818392016390
- Basic UDI-DI
- 081006243SIG1ZT
- Direct Marketing DI
- 00818392013801008183920160480081839201602400818392013641008183920160170081839201599700818392016390
- EMDN Code
- A0201060301 Insulin syringes with safety systems and fixed needles, single-use
- Device Class
- Class IIa
- 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
Show 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