Solojekt
by I'M Medicare SARL EUDAMED
Active
Ref IT-13-37-00Model SOLOJEKT
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number611800222SYRINSBL | Date23 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 28620234405 Issued
Quality management system EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 27 Jan 2026
- Expires
- 19 Jan 2031
Specification
- Device Name
- Sterile Insulin Syringe
- Model / Reference
- SOLOJEKT, IT-13-37-00
- Primary DI / UDI-DI
- 06118002224189
- Basic UDI-DI
- 611800222SYRINSBL
- EMDN Code
- A02010601 Insulin syringes with fixed needle, single-use
- Device Class
- Class IIa
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- MA-MF-000037665
- Authorised representative
- EUCEREP B.V. NL-AR-000001966
Other devices from I'M Medicare SARL
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