Identity
- Trade Name
- SOLOJEKT EUDAMED
- Device Name
- Class I devices with a measuring function EUDAMED
- Model / Reference
- SOLOJEKT BULK EUDAMEDIT-08-00-BS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06118002224868 EUDAMED
- Basic UDI-DI
- 611800222SRGBLK4Z EUDAMED
- Unit of Use DI
- 16118002224865 EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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 I — 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 | 611800222SRGBLK4Z | Class I | 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 02ea7745-b25d-40d9-951d-e884297a1d06 61 fields · synced Jun 19, 2026