Identity
- Trade Name
- MAGICL Syphilis (CLIA) EUDAMED
- Device Name
- MAGICL Syphilis (CLIA) EUDAMED
- Model / Reference
- / EUDAMEDCLIA3062A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414799040 EUDAMED06954414732290 EUDAMED06954414732504 EUDAMED
- Basic UDI-DI
- B-06954414799040 EUDAMED695441479904KY EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C 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 Syphilis (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-06954414799040 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414799040 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 92161a90-7e96-4a97-8140-40cf29b3973d 61 fields · synced Sep 18, 2026
- EUDAMED fbf80177-52d2-42f7-9424-2d107105bcf5 61 fields · synced Jul 23, 2026
- EUDAMED 2d7dc689-ed07-4969-865d-45a743970303 61 fields · synced Sep 18, 2026