Identity
- Trade Name
- SOLOJEKT EUDAMED
- Device Name
- STERILE INSULIN SYRINGE EUDAMED
- Model / Reference
- SOLOJEKT EUDAMEDIT-15-39-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06118002224295 EUDAMED
- Basic UDI-DI
- 611800222SYRINSBL EUDAMED
- EMDN Code
- A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Solojekt by I'M Medicare SARL — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 611800222SYRINSBL | Class IIa | Active |
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Manufacturer
- Manufacturer
- I'M Medicare SARL
- EUDAMED SRN
- MA-MF-000037665
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (1)
- EUDAMED 343283b1-cc7d-4ba8-ab70-9b2366c83624 61 fields · synced Jun 18, 2026