Solojekt Ad
by I'M Medicare SARL 126 variants
Ref IT-02-21-LSModel SOLOJEKT AD
Active
CE MDR
Valid until
19 Jan 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number611800222ADRUPVZ 06118002220105 | Date21 Apr 2026 | StatusActive |
Certificates
- 28620234405 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 27 Jan 2026
- Expires
- 19 Jan 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ad/Rup Syringe with Needle
- Model / Reference
- SOLOJEKT AD, IT-02-21-LS
- Primary DI / UDI-DI
- 06118002220105
- Basic UDI-DI
- 611800222ADRUPVZ
- EMDN Code
- A020199 Syringes, single-use - other
- Device Class
- Class IIa
- EU 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