Identity
- Trade Name
- MAGICL IL-6 (CLIA) EUDAMED
- Device Name
- MAGICL IL-6 (CLIA) EUDAMED
- Model / Reference
- / EUDAMEDCLIA3046A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414798388 EUDAMED06954414750577 EUDAMED06954414733709 EUDAMED06954414750669 EUDAMED06954414750652 EUDAMED06954414729023 EUDAMED06954414750560 EUDAMED06954414750676 EUDAMED
- Basic UDI-DI
- B-06954414798388 EUDAMED695441479838LC EUDAMED
- EMDN Code
- W01030609 INTERLEUKIN 6 (IL-6) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Türkiye EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Magicl Il-6 (clia) by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06954414798388 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414798388 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (8)
- EUDAMED 2861b943-3108-4bdf-a89b-3051d1e2ed5b 61 fields · synced Aug 2, 2026
- EUDAMED f5d2cef8-b47c-4e1c-8c82-f32306d0747a 61 fields · synced Jul 9, 2026
- EUDAMED cac5f6e9-85de-420d-ae1d-b117a5d94fd8 61 fields · synced Jul 11, 2026
- EUDAMED ae1d9b5f-d25a-4f59-856a-bbc9b75f382e 61 fields · synced Jul 23, 2026
- EUDAMED 6f7782ac-aa12-47fe-b9f0-c1f2db7dca99 61 fields · synced Jul 25, 2026
- EUDAMED 642cbc78-11a0-413a-8794-e8d70280dde6 61 fields · synced Jul 28, 2026
- EUDAMED ed043cca-ca2a-4d94-bf59-98db66c7946b 61 fields · synced Jul 30, 2026
- EUDAMED 8c4e6905-2ef2-4cba-b082-43a09ad279d2 61 fields · synced Aug 2, 2026